A randomized study of a method for optimizing adolescent assent to biomedical research.

PubMed

Annett, Robert D; Brody, Janet L; Scherer, David G; Turner, Charles W; Dalen, Jeanne; Raissy, Hengameh

2017-01-01

Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

PubMed

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-07-21

In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented.

A qualitative study to assess school nurses' views on vaccinating 12–13 year old school girls against human papillomavirus without parental consent

PubMed Central

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-01-01

Background In the UK, parental consent for the routine vaccination of 12–13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. Methods HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix™). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. Results School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Conclusion Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented. PMID:19622145

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

PubMed

Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

2016-09-09

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

PubMed

Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

2017-05-01

To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001). Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

PubMed Central

Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

2015-01-01

Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions. PMID:26384724

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

PubMed

Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

2013-06-01

A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.

A Randomized Study of a Method for Optimizing Adolescent Assent to Biomedical Research

PubMed Central

Annett, Robert D.; Brody, Janet L.; Scherer, David G.; Turner, Charles W.; Dalen, Jeanne; Raissy, Hengameh

2018-01-01

Purpose Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Methods Families were randomly assigned to remain together or separated during a consent/assent process, the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Results 64 adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. Conclusions The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent’s informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a “diffusion of responsibility” effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits. PMID:28949898

Involving parents from the start: formative evaluation for a large randomised controlled trial with Botswana Junior Secondary School students.

PubMed

Vig, Jessica; Miller, Kim S; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

2016-01-01

While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomised controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13-17) from rural, peri-urban and urban junior secondary schools in Botswana. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The focus group discussions (FGDs) provided valuable information and insights that helped strengthen the study. As a result of parents' feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child's HSV-2 test results.

Involving parents from the start: Formative evaluation for a large RCT with Botswana Junior Secondary School students

PubMed Central

Miller, Kim S.; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

2016-01-01

While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomized controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13–17) from rural, peri-urban, and urban Botswana junior secondary schools. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The FGDs provided valuable information and insights that helped strengthen the study. As a result of parents’ feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child’s HSV-2 test results. PMID:27002354

Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

PubMed Central

Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

2013-01-01

Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Malviya, Shobha; Philipson, Sandra J

2005-04-01

To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form. Randomized clinical study. The preoperative waiting area of a larger tertiary care children's hospital. A total of 305 parents of children scheduled for minor elective surgical procedures. Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure. Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors. Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version. Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.

34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent.

PubMed

Brabin, Loretta; Roberts, Stephen A; Kitchener, Henry C

2007-02-09

The first vaccine to prevent human papillomavirus (HPV) and cervical cancer has been licensed, and in future, vaccination may be routinely offered to 10-14 year old girls. HPV is a sexually transmitted virus and some parents may refuse consent for vaccination. Under-16s in the UK have a right to confidential sexual health care without parental consent. We investigated parents' views on making available HPV vaccination to adolescent minors at sexual health clinics without parental consent. This was a semi-qualitative analysis of views of parents of 11-12 year old school children collected as part of a population-based survey of parental attitudes to HPV vaccination in Manchester. Parents were firstly asked if they agreed that a well-informed child should be able to request vaccination at a sexual health clinic without parental consent, and secondly, to provide a reason for this answer. Ethical perspectives on adolescent autonomy provided the framework for descriptive analysis. 307 parents answered the question, and of these, 244 (80%) explained their views. Parents with views consistent with support for adolescent autonomy (n = 99) wanted to encourage responsible behaviour, protect children from ill-informed or bigoted parents, and respected confidentiality and individual rights. In contrast, 97 parents insisted on being involved in decision-making. They emphasised adult responsibility for a child's health and guidance, erosion of parental rights, and respect for cultural and moral values. Other parents (n = 48) wanted clearer legal definitions governing parental rights and responsibilities or hoped for joint decision-making. Parents resistant to adolescent autonomy would be less likely to consent to future HPV vaccination, (67%) than parents supporting this principle (89%; p < 0.001). In the UK, the principle of adolescent autonomy is recognised and logically should include the right to HPV vaccination, but this may concern parents who would otherwise approve vaccination.

But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa

PubMed Central

Slack, C M; Strode, A E

2018-01-01

Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for supporting documentation? In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances, but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach. PMID:29887973

Children, biobanks and the scope of parental consent

PubMed Central

Hens, Kristien; Cassiman, Jean-Jacques; Nys, Herman; Dierickx, Kris

2011-01-01

The use of stored tissue samples from children for genetic research raises specific ethical questions that are not all analogous to those raised when adult participants are concerned. These include issues with regard to consent, as it is typically a parent who consents to the use of samples from children. In this paper, we discuss the scope of parental consent. This scope has a temporal dimension and one related to the content of consent. It is not questioned that the temporal scope of parental consent is limited and that young adults have the right to decide on the fate of their samples when they reach the age of maturity. With regard to the content of consent, the question remains whether parents are allowed to give full broad consent to any possible future research on the samples of their children. We argue that they should not be allowed to do so, based on two premises. First, it is generally acknowledged that children have a right to express their own values and that they should be given the opportunity to develop their own autonomy as they grow older. Second, research and science are not completely value-free and some types of research may be more sensitive than other types. Children should be given the opportunity to express their values also in this respect. PMID:21386873

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

PubMed

Wilman, E; Megone, C; Oliver, S; Duley, L; Gyte, G; Wright, J M

2015-11-04

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials? A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature. Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent. Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

Care and Consent.

ERIC Educational Resources Information Center

Gottesman, Roberta

1981-01-01

Discusses the legal ramifications of informed consent for medical treatment of schoolchildren, including the problems posed by parents unwilling to give adequate medical protection to their children because of religious or other reasons. Covers the types of medical care that minors can receive without parental consent. (WD)

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... available technology, to ensure that the person providing consent is the child's parent. (2) Existing... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... children, including consent to any material change in the collection, use, or disclosure practices to which...

Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

PubMed

Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

2015-08-01

Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

Obtaining waivers of parental consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health prevention research.

PubMed

Flores, Dalmacio; McKinney, Ross; Arscott, Joyell; Barroso, Julie

Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data. Standard consent policies may inadvertently exclude youth who are at high risk for negative health outcomes or may potentially put them at risk because of forced disclosure of sexual orientation. Securing a waiver addresses these concerns and allows for rich data, which is critical for providers to have a deeper understanding of their unique sexual health needs. To properly safeguard and encourage research informed by SMY, parental consent waivers may be necessary. Copyright © 2017 Elsevier Inc. All rights reserved.

Parental views on informed consent for expanded newborn screening.

PubMed

Moody, Louise; Choudhry, Kubra

2013-09-01

An increasing array of rare inherited conditions can be detected as part of the universal newborn screening programme. The introduction and evaluation of these service developments require consideration of the ethical issues involved and appropriate mechanisms for informing parents and gaining consent if required. Exploration of parental views is needed to inform the debate and specifically consider whether more flexible protocols are needed to fit with the public perception of new developments in this context. This study has been undertaken to explore perceptions and attitudes of parents and future parents to an expanded newborn screening programme in the United Kingdom and the necessary information provision and consent processes. A mixed methods study involving focus groups (n = 29) and a web-survey (n = 142) undertaken with parents and future parents. Parents want guaranteed information provision with clear decision-making powers and an awareness of the choices available to them. The difference between existing screening provision and expanded screening was not considered to be significant enough by participants to warrant formal written, informed consent for expanded screening. It is argued that the ethical review processes need to be more flexible towards the provision of information and consent processes for service developments in newborn screening. © 2011 John Wiley & Sons Ltd.

Informed consent in paediatric critical care research--a South African perspective.

PubMed

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Parental decision making around perinatal autopsy: a qualitative investigation.

PubMed

Meaney, Sarah; Gallagher, Stephen; Lutomski, Jennifer E; O'Donoghue, Keelin

2015-12-01

Decades of decline in uptake rates of perinatal autopsies has limited investigation into the causes and risk factors for stillbirth. This study aimed to qualitatively explore perinatal autopsy decision-making processes in parents who experienced antepartum and intrapartum stillbirths. A qualitative semi-structured interview format was utilized. The line of questioning centred on how parents came to decide on consenting or declining to have a perinatal autopsy undertaken. Interpretative phenomenological analysis was employed as the analytic strategy. Purposive sampling was used to recruit 10 parents who either consented or declined autopsy from a large tertiary maternity hospital in Cork Ireland, where there were 30 stillbirths in 2011. Findings revealed four superordinate themes influencing parents' decision-making which varied with type of stillbirth experienced. Those parents who experienced antepartum stillbirths were more likely to consent; thus, knowing that the child was stillborn prior to delivery rather than on the day of delivery was associated with consent. In fact, these parents had more time for meaning-making; those consenting wanted to rule out self-blame and were fearful about future pregnancies. Parents who declined autopsy wanted to protect their infant from further harm. Interestingly, parents' knowledge and understanding of the autopsy itself were acquired primarily from public discourse. Parents' decision-making regarding autopsy is profoundly affected by their emotional response to stillbirth; clinicians and other health professionals may play a key role, especially if they can address parental concerns regarding the invasiveness of the autopsy procedure. © 2014 John Wiley & Sons Ltd.

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

PubMed

Allmark, P; Mason, S

2006-08-01

To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Consent validity was found to compare favourably with similar trials examined in the Euricon study. Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

Measles high school vaccination program, 2014-2015: online survey of parents in NSW, Australia.

PubMed

Nicholl, Sonya; Seale, Holly; Campbell-Lloyd, Sue

2018-06-14

In 2014, a high school-based measles supplementary immunisation activity (SIA) took place in New South Wales (NSW), Australia, in response to a large number of adolescents being identified as undervaccinated or unvaccinated against measles. The program focused on areas of NSW where previous measles outbreaks had occurred and where large numbers of undervaccinated adolescents lived. More than 11 000 students were vaccinated in 2014, and the program continued in 2015, when more than 4000 students in Years 11 and 12 were vaccinated. Parents of students vaccinated during the program were surveyed to determine their level of satisfaction with the program. An online link to the anonymous survey with instructions was sent in a text message between August 2015 and May 2016 to parents of students who had consented or been vaccinated during the 2014 and 2015 measles, mumps and rubella (MMR) supplementary immunisation activities (SIAs). Responses were received from parents in all Local Health Districts (LHDs), and response rates ranged from <1% to 21% across different districts with 59% of the total number of complete responses from three LHDs. Overall, parents were satisfied with the MMR program, its resources and how it was implemented. Suggestions were received to improve consent processes, increase student involvement and increase school staff accountability. More than half of the parents reported difficulty finding their child's previous vaccination record. Improving vaccination record access and management was highlighted as an area of improvement in the program. Although response rates were low, the survey has generated important ideas that may help to further improve implementation of school vaccination programs, including allowing electronic consent, increasing student engagement, improving access to previous vaccination records and increasing school staff accountability.

Obtaining active parental consent for school-based research: a guide for researchers.

PubMed

Wolfenden, Luke; Kypri, Kypros; Freund, Megan; Hodder, Rebecca

2009-06-01

Schools increasingly require researchers to obtain active parental consent for students to participate in health research. We sought to identify effective strategies for the recruitment of child research participants through schools. A search of Medline, PsycINFO, Educational Resources Information Center, ProQuest 5000 and the Cochrane Library electronic databases was conducted for the period 1988 to 2008. The review found evidence that the following strategies may be effective in enhancing participation rates: 1) promotion of the research to school principals, teachers, parents and students; 2) dissemination of study information using methods allowing direct contact with parents (i.e. telephone or face-to-face); 3) provision of incentives to teachers, students and at a class level; 4) making reminder contacts; and 5) having a member of the research team co-ordinate and closely monitor the recruitment process. Application of these strategies should reduce the risk of non-response and other biases that result from selective non-participation. Further randomised controlled trials of these and other strategies are required to strengthen the evidence base.

Does parental consent for birth control affect underage pregnancy rates? The case of Texas.

PubMed

Girma, Sourafel; Paton, David

2013-12-01

Previous work based on conjectural responses of minors predicted that the 2003 Texas requirement for parental consent for state-funded birth control to minors would lead to a large increase in underage pregnancies. We use state- and county-level data to test this prediction. The latter allow us to compare the impact of parental consent in counties with and without state-funded family planning clinics. We control for characteristics systematically correlated with the presence of state-funded clinics by combining difference-in-difference estimation with propensity score-weighted regressions. The evidence suggests that the parental consent mandate led to a large decrease in attendance at family planning clinics among teens but did not lead to an increase in underage pregnancies.

Parental attitudes and information needs in an adolescent HPV vaccination programme

PubMed Central

Stretch, R; Roberts, S A; McCann, R; Baxter, D; Chambers, G; Kitchener, H; Brabin, L

2008-01-01

We sent a questionnaire to 38% (1084) of 2817 parents whose daughters had been offered human papillomavirus vaccination and who had agreed to participate. Of these, 60% (651) returned a questionnaire. Responses suggested that fact sheets and parent information evenings confirmed, rather than changed, consent decisions. The views of active refusers on safety and efficacy may be difficult to change, lowering vaccine coverage. PMID:18985038

Parental Refusal to Consent for Evaluation: A Legal Analysis with Implications for School Psychologists

ERIC Educational Resources Information Center

Etscheidt, Susan; Clopton, Kerri; Haselhuhn, Charlotte

2012-01-01

The decision to begin the process for special education eligibility has complexities impacting children, parents, teachers, and schools. The Individuals with Disabilities Education Improvement Act (IDEA) eligibility provisions specify the need to obtain consent prior to evaluation and options when consent cannot be obtained. School psychologists…

34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

Code of Federal Regulations, 2010 CFR

2010-07-01

... which consent is sought, in the parent's native language or other mode of communication; (2) The parent... proficiency, means the language or mode of communication normally used by the parent of a child eligible under... child's parent, or other family member; (2) The address of the child; (3) A personal identifier, such as...

What Can Parents Do? A Review of State Laws Regarding Decision Making for Adolescent Drug Abuse and Mental Health Treatment

PubMed Central

Kerwin, MaryLouise E.; Kirby, Kimberly C.; Speziali, Dominic; Duggan, Morgan; Mellitz, Cynthia; Versek, Brian; McNamara, Ashley

2013-01-01

This study examined US state laws regarding parental and adolescent decision-making for substance use and mental health inpatient and outpatient treatment. State statues for requiring parental consent favored mental health over drug abuse treatment and inpatient over outpatient modalities. Parental consent was sufficient in 53%–61% of the states for inpatient treatment, but only for 39% – 46% of the states for outpatient treatment. State laws favored the rights of minors to access drug treatment without parental consent, and to do so at a younger age than for mental health treatment. Implications for how these laws may impact parents seeking help for their children are discussed. PMID:25870511

Fertility and Parental Consent for Minors to Receive Contraceptives

PubMed Central

Zavodny, Madeline

2004-01-01

Objectives. I examined the effect of imposing a requirement for parental consent before minors can receive medical contraceptives. Methods. Birth and abortions among teens, relative to adults, in a suburban Illinois county that imposed a parental consent requirement in 1998 were compared with births and abortions in nearby counties during the period 1997–2000. Results. The relative proportion of births to women under age 19 years in the county rose significantly compared with nearby counties, whereas the relative proportion of abortions to women under age 20 years declined insignificantly, with a relative increase in the proportion of pregnancies (births and abortions) to young women in the county. Conclusions. Imposing a parental consent requirement for contraceptives, but not abortions, appears to raise the frequency of pregnancies and births among young women. PMID:15284042

A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

PubMed

Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

2017-02-01

Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

Success of University Student Volunteers in Obtaining Consent for Reviewing Private Health Information for Emergency Research.

PubMed

Kramer, Adam I; Stephenson, Elizabeth; Betel, Adam; Crudden, Johanna; Boutis, Kathy

2017-01-01

This study aimed to determine the success of university student volunteers in obtaining consent from parents to allow review of their child's personal health information (PHI) for emergency research screening. This study also aimed to examine the variables associated with successful consent. This was a prospective cross-sectional study conducted at a pediatric emergency department (ED). University students, who functioned as delegates of the health information custodian, approached parents for consent. Of 2,506 parents, 1,852 (73.9%) provided consent to allow review of their child's PHI for research screening. Variables associated with successful consent were high (≥12 months) versus low (<12 months) volunteer experience (OR = 2.0), research related (vs. unrelated) to the child's chief complaint (OR = 2.0), child treated regularly by specialists at the study institution (OR = 1.7), and ED presentation mid-week vs. weekend (OR = 1.7) and morning vs. evening presentation (OR = 1.4). When approached by a university student volunteer, about 25% of parents declined to have their child's PHI reviewed for research screening. This model of obtaining consent may put some emergency research at risk for selection bias. Variables that increase the odds of successful consent can be considered in program design to improve the effectiveness of this model.

What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders.

PubMed

Wood, Fiona; Morris, Lucy; Davies, Myfanwy; Elwyn, Glyn

2011-08-01

The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12-13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Qualitative study using semi-structured interviews. A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Overriding the parents' wishes was perceived as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting.

Parental Consent for Abortion and the Judicial Bypass Option in Arkansas: Effects and Correlates

PubMed Central

Joyce, Ted

2010-01-01

CONTEXT In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. METHODS Using state Department of Health data on 7,463 abortions among 15–19-year-olds over the period 2001–2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors’ using the bypass procedure or having a second-trimester abortion. RESULTS No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. CONCLUSIONS States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. PMID:20887286

Parental consent for abortion and the judicial bypass option in Arkansas: effects and correlates.

PubMed

Joyce, Ted

2010-09-01

In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. Using state health department data on 7,463 abortions among 15-19-year-olds over the period 2001-2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors' using the bypass procedure or having a second-trimester abortion. No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. Copyright © 2010 by the Guttmacher Institute.

Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

PubMed

Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

2018-06-01

Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

Unconstitutionality of abortion laws affirmed.

PubMed

1979-08-01

A federal appeals court has affirmed lower court rulings that substantial portions of the Illinois' 1975 Abortion Act and 1977 Abortion Parental Consent Act are unconstitutional. The 7th Court adopted an April 12, 1978 district court opinion that invalidated several sections of the Illinois 1975 abortion statute, including parental and spousal consent requirements and provisions requiring that a woman be informed of the "physical competency" of the fetus at the time the abortion was to be performed. The appeals court specifically addressed the statute's provision making a liveborn fetus resulting from an abortion a ward of the state, unless the abortion was performed to save the woman's life. Regarding the 1977 Parental Consent Act, the 7th Circuit reaffirmed its August 1978 ruling that it is unconstitutional to require an unmarried minor to have the consent of both parents or, if they refused consent, a circuit court judge before undergoing an abortion. The appeals court also agreed with the lower court's November 2nd ruling that the Act's requirement of a 48-hour delay between the time the minor gives her consent and the performance of an abortion violated the equal protection clause of the 14th amendment.

Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

PubMed

Kabakama, Severin; Gallagher, Katherine E; Howard, Natasha; Mounier-Jack, Sandra; Burchett, Helen E D; Griffiths, Ulla K; Feletto, Marta; LaMontagne, D Scott; Watson-Jones, Deborah

2016-08-19

Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90-70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.

Counseling Minors Without Parental Consent.

ERIC Educational Resources Information Center

Croxton, Tom A.; And Others

1988-01-01

Examines from legal and psychological perspectives counseling services that are provided to minors without parental knowledge or consent. Explores current mental health agency policies and practices, and makes recommendations regarding the counseling needs and rights of minors. (SKC)

Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.

PubMed

Nabulsi, Mona; Khalil, Yvette; Makhoul, Jihad

2011-07-01

Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. To explore such perceptions and attitudes in Lebanese parents. 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation. Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

Parental consent for abortion: impact of the Massachusetts law.

PubMed Central

Cartoof, V G; Klerman, L V

1986-01-01

This study assessed the impact of Massachusetts' parental consent law, which requires unmarried women under age 18 to obtain parental or judicial consent before having an abortion. Data were analyzed on monthly totals of abortions and births to Massachusetts minors prior to and following the April 1981 implementation of the law. Findings indicate that half as many minors obtained abortions in the state during the 20 months after the law went into effect as had done so previously. More than 1,800 minors residing in Massachusetts traveled to five surrounding states during these 20 months to avoid the statute's mandates. This group accounts for the reduction in in-state abortions. A small number of minors (50 to 100) bore children rather than aborting during 1982, perhaps because of the law. Findings suggest that this state's parental consent law had little effect on adolescent's pregnancy-resolution behavior. PMID:3953915

Protecting Adolescents' Right to Seek Treatment for Sexually Transmitted Diseases without Parental Consent: The Arizona Experience with Senate Bill 1309

PubMed Central

Goodwin, Kimberly D.; Taylor, Melanie M.; Brown, Erin C. Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G.; Mickey, Tom; England, Bob

2012-01-01

In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent. PMID:22547855

Protecting adolescents' right to seek treatment for sexually transmitted diseases without parental consent: the Arizona experience with Senate Bill 1309.

PubMed

Goodwin, Kimberly D; Taylor, Melanie M; Brown, Erin C Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G; Mickey, Tom; England, Bob

2012-01-01

In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent.

Parental comprehension following informed consent for pediatric cataract surgery.

PubMed

Erraguntla, Vasudha; De la Huerta, Irina; Vohra, Sunita; Abdolell, Mohamed; Levin, Alex V

2012-04-01

To investigate the effectiveness of information transfer by the pediatric cataract surgeon to the parents or guardians of children during the informed-consent process. Prospective observational case series. Parents of 31 children undergoing cataract surgery. Parents were enrolled from the clinical practice of 1 pediatric cataract surgeon. Using a checklist developed in consultation with other pediatric cataract surgeons, the surgeon discussed the nature of the disease, the course without surgical intervention, the surgical procedure, the risks and benefits, and the postoperative care. Immediately after the discussion, parents were invited to complete a questionnaire assessing information recall. Analysis of variance and the t test were used to determine associations between questionnaire scores and demographic variables. The surgeon subsequently called parents and discussed again the issues that they had not remembered correctly, as identified by the questionnaire responses. The study and data accumulation were carried out with the approval of the Research Ethics Board at The Hospital for Sick Children, Toronto, Ont. Informed consent for the research was obtained from the parents or legal guardians of the children enrolled in the study. The study adhered to the tenets of the Declaration of Helsinki. Of 31 parents, 18 (58%) overestimated their understanding of the informed-consent discussion. Parents scored well on questions about the nature of the disease and the postoperative follow-up but scored lower on questions regarding surgical risks and outcomes. Parents identified several barriers to understanding, including the large amount of information, stress, and preoccupation with the child. No association was noted between the level of understanding and demographic factors. Parents may overestimate their understanding of informed-consent discussions. Some parents may be overly optimistic about risks and outcomes. The surgeon's follow-up communication with parents that addressed aspects insufficiently understood during the initial discussion provided a way of improving comprehension. Copyright © 2012. Published by Elsevier Inc.

Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

PubMed

Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

2009-10-01

Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

Participation of Adolescent Girls in a Study of Sexual Behaviors: Balancing Autonomy and Parental Involvement

PubMed Central

Short, Mary B.; Wiemann, Constance; Rosenthal, Susan L.

2009-01-01

Study Objective The process of research with adolescents should balance parental involvement and adolescent autonomy. The attendance of parents and peers at research study visits of girls participating in a 6-month study of topical microbicide acceptability is described, as well as the participants’ conversations with their parents. Methods Girls, 14 through 21 years, were recruited from previous studies (3%), advertisements (14%), clinics (17%), and recommendations by friends (66%) to participate. Girls under 18 years were required to have parental consent, but parents could provide verbal phone consent as long as a signed consent form was returned before participation. Results The 208 participants were 41% African-American, 30% Hispanic, and 29% Caucasian. Girls averaged 18 years of age, and 95 (46%) were under 18. Seventeen percent of parents attended the first visit; all but one was with a daughter of less than 18 years. The mothers of older adolescents were less likely to attend the appointment with them. More Caucasian than African-American girls came with a mother. Parental attendance decreased at follow-up visits. Thirty-seven percent of girls brought a peer to the first visit; there were no age or race/ethnic differences. There was no relationship between attending with a parent or peer and talking to a parent about the study. Some adolescents obtained parental consent to participate in the study while keeping their sexual behaviors private. Conclusions Parental attendance at study visits may not be marker of parental involvement with the study. Creative ways for balancing concerns about confidentiality, promotion of autonomy, and adult involvement should be considered. PMID:19345916

Counterproductive Effects of Parental Consent in Research Involving LGBTTIQ Youth: International Research Ethics and a Study of a Transgender and Two-Spirit Community in Canada

ERIC Educational Resources Information Center

Taylor, Catherine G.

2008-01-01

This article offers an evidence-based argument for exempting the majority of LGBTTIQ youth from parental consent requirements in research studies. The argument is grounded in international research ethics principles and social science research studies of risks to the well-being of LGBTTIQ youth. A schema derived from consent concepts used in…

Consent to autopsy for neonates.

PubMed

McHaffie, H E; Fowlie, P W; Hume, R; Laing, I A; Lloyd, D J; Lyon, A J

2001-07-01

To determine parents' views on autopsy after treatment withdrawal. Face to face interviews with 59 sets of bereaved parents (108 individual parents) for whose 62 babies there had been discussion of treatment withdrawal. All except one couple were asked for permission for postmortem examination; 38% refused. The main reasons for declining were concerns about disfigurement, a wish to have the child left in peace, and a feeling that an autopsy was unnecessary because the parents had no unanswered questions. The diagnosis, the age of the child, and the approach of the consultant appeared to influence consent rates. Of those who agreed to autopsies, 92% were given the results by the neonatologist concerned. Whether or not they had agreed to the procedure, at 13 months no parent expressed regrets about their decision. Autopsy rates in the East of Scotland stand at 62%. Parents' perceptions are an important element in consent to postmortem examination.

When Can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

PubMed

Taylor, Mark J; Dove, Edward S; Laurie, Graeme; Townend, David

2017-11-13

Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data. © The Author 2017. Published by Oxford University Press.

Voluntary Informed Consent in Paediatric Oncology Research.

PubMed

Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

2016-07-01

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

[Informed consent consultation as a part of patient safety in pediatric traumatology].

PubMed

Kraus, R; Heberer, J

2013-10-01

In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

PubMed

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

Abortion among Adolescents.

ERIC Educational Resources Information Center

Adler, Nancy E.; Ozer, Emily J.; Tschann, Jeanne

2003-01-01

Reviews the current status of abortion laws pertaining to adolescents worldwide, examining questions raised by parental consent laws in the United States and by the relevant psychological research (risk of harm from abortion, informed consent, consequences of parental involvement in the abortion decision, and current debate). Discusses issues…

Consent to treatment by minors attending accident and emergency departments: guidelines.

PubMed Central

Williams, L; Harris, A; Thompson, M; Brayshaw, A

1997-01-01

The absolute right to refuse medical treatment, even if the reasons are irrational, is confined to competent adults. Children under 16 years can give legal consent to treatment in the absence of consent from those with parental responsibility. Children under 18 years do not, however, have an absolute right to consent, or refuse to consent, to treatment. The views of children assume increasing importance with age and maturity. Accident and emergency medical and nursing staff may face difficult decisions when children, or those with parental responsibility, refuse to consent to medical treatment. This paper presents guidelines designed to guide the decision making process in immediately or potentially life threatening conditions and in non-life-threatening conditions. Images Figure 1 Figure 2 p289-a PMID:9315927

The accompanying adult: authority to give consent in the UK.

PubMed

Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

2007-05-01

Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project.

PubMed

Ulph, Fiona; Wright, Stuart; Dharni, Nimarta; Payne, Katherine; Bennett, Rebecca; Roberts, Stephen; Walshe, Kieran; Lavender, Tina

2017-10-01

Participation in the UK Newborn Bloodspot Screening Programme (NBSP) requires parental consent but concerns exist about whether or not this happens in practice and the best methods and timing to obtain consent at reasonable cost. To collate all possible modes of prescreening communication and consent for newborn (neonatal) screening (NBS); examine midwives', screening professionals' and users' views about the feasibility, efficiency and impact on understanding of each; measure midwives' and parents' preferences for information provision; and identify key drivers of cost-effectiveness for alternative modes of information provision. Six study designs were used: (1) realist review - to generate alternative communication and consent models; (2) qualitative interviews with parents and health professionals - to examine the implications of current practice for understanding and views on alternative models; (3) survey and observation of midwives - to establish current costs; (4) stated preference surveys with midwives, parents and potential future parents - to establish preferences for information provision; (5) economic analysis - to identify cost-effectiveness drivers of alternative models; and (6) stakeholder validation focus groups and interviews - to examine the acceptability, views and broader impact of alternative communication and consent models. Providers and users of NBS in England. Study 2: 45 parents and 37 health professionals; study 3: 22 midwives and eight observations; study 4: 705 adults aged 18-45 years and 134 midwives; and study 6: 12 health-care professionals and five parents. The realist review identified low parental knowledge and evidence of coercive consent practices. Interview, focus group and stated preference data suggested a preference for full information, with some valuing this more than choice. Health professionals preferred informed choice models but parents and health professionals queried whether or not current consent was fully informed. Barriers to using leaflets effectively were highlighted. All studies indicated that a 'personalised' approach to NBS communication, allowing parents to select the mode and level of information suited to their learning needs, could have added value. A personalised approach should rely on midwife communication and should occur in the third trimester. Overall awareness was identified as requiring improvement. Starting NBS communication by alerting parents that they have a choice to make and telling them that samples could be stored are both likely to enhance engagement. The methods of information provision and maternal anxiety causing additional visits to health-care professionals were the drivers of relative cost-effectiveness. Lack of data to populate an economic analysis, confirmed by value of information analysis, indicated a need for further research. There are some limitations with regard to the range of participants used in studies 2 and 3 and so caution should be exercised when interpreting some of the results. This project highlighted the importance of focusing on information receipt and identified key communication barriers. Health professionals strongly preferred informed consent, which parents endorsed if they were made aware of sample storage. Uniform models of information provision were perceived as ineffective. A choice of information provision was supported by health professionals and parents, which both enhances cost-effectiveness and improves engagement, understanding and the validity of consent. Remaining uncertainties suggest that more research is needed before new communication modes are introduced into practice. Future research should measure the impact of the suggested practice changes (informing in third trimester, information toolkits, changed role of midwife). Current Controlled Trials ISRCTN70227207. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 55. See the NIHR Journals Library website for further project information.

Constitutional Law: Abortion, Parental Consent, Minors' Right to Due Process, Equal Protection and Privacy

ERIC Educational Resources Information Center

Child, Barbara

1975-01-01

In State v. Koome, the Washington Supreme Court has striken that state's statute regarding parental consent for a minor's abortion. Implications of the finding for a minor's right to due process, equal protection, and privacy are discussed. (LBH)

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

PubMed Central

Molyneux, Sassy; Njue, Maureen; Boga, Mwanamvua; Akello, Lilian; Olupot-Olupot, Peter; Engoru, Charles; Kiguli, Sarah; Maitland, Kathryn

2013-01-01

Objective To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. Methods A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. Findings Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. Conclusion While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach. PMID:23408950

Under-age girls and contraception: the parent's right to be informed.

PubMed

Brahams, Diana

1983-08-06

A British barrister considers the issue of whether the giving of advice or the prescribing of contraceptives to girls younger than 16 without parental consent constitutes criminal conduct by the physician. Brahams examines relevant criminal and family law, common law, recent court decisions, and Department of Health and Human Services policy concerning the minor's right to consent, parental interests, and physician responsibilities.

25 CFR 43.14 - Consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS... students, without the written consent of the parents or of an eligible student, to any party other than the... schools or school systems at which a student is interested in enrolling. The student or parent must be...

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

Social Physique Anxiety and Intention to Be Physically Active: A Self-Determination Theory Approach

ERIC Educational Resources Information Center

Sicilia, Álvaro; Sáenz-Alvarez, Piedad; González-Cutre, David; Ferriz, Roberto

2016-01-01

Purpose: Based on self-determination theory, the purpose of this study was to analyze the relationship between social physique anxiety and intention to be physically active, while taking into account the mediating effects of the basic psychological needs and behavioral regulations in exercise. Method: Having obtained parents' prior consent, 390…

Factors influencing parental consent in a hypothetical pediatric vaccine trial in a developing country setting: a questionnaire study.

PubMed

Serce, Ozge; Gonen, Ismail; Bakir, Mustafa

2015-01-01

Clinical vaccine trials have been lacking in the pediatric population due to lower consent rate of the parents. We assessed characteristics of the parents, and motives and barriers underlying the decision process. The results of the questionnaire were evaluated by multivariate analysis. Parents who opted in were younger and more often employed than the parents who opted out. The most important motives were receiving detailed information about trial and benefits to human health. The qualified education of medical community and public about the rationale and benefits of trials is essential for opt-in.

Assessing physician-parent communication during emergency medical procedures in children: an observational study in a low-literacy Latino patient population.

PubMed

Dahl, Aaron; Sinha, Madhumita; Rosenberg, David I; Tran, Melissa; Valdez, André

2015-05-01

Effective physician-patient communication is critical to the clinical decision-making process. We studied parental recall of information provided during an informed consent discussion process before performance of emergency medical procedures in a pediatric emergency department of an inner-city hospital with a large bilingual population. Fifty-five parent/child dyads undergoing emergency medical procedures were surveyed prospectively in English/Spanish postprocedure for recall of informed consent information. Exact logistic regression was used to predict the ability to name a risk, benefit, and alternative to the procedure based on a parent's language, education, and acculturation. Among English-speaking parents, there tended to be higher proportions that could name a risk, benefit, or alternative. Our regression models showed overall that the parents with more than a high school education tended to have nearly 5 times higher odds of being able to name a risk. A gap in communication may exist between physicians and patients (or parents of patients) during the consent-taking process, and this gap may be impacted by socio-demographic factors such as language and education level.

Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

PubMed

Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

2014-09-30

Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before embarking on recruitment of children for studies, formative research on the parental consent process is suggested.

Would Parents Consent to a Comparative Effectiveness Trial of Oral Doxycycline Versus Intravenous Ceftriaxone for the Treatment of Children with Lyme Meningitis?

PubMed

Garro, Aris; Koster, Michael; LaRue, Molly; Hipolito, Evelyn; Congdon, Elizabeth; Burnett, Kathleen; Cullen, Nicole; Nigrovic, Lise E

2018-05-01

Children with Lyme meningitis are often treated with intravenous ceftriaxone, although oral doxycycline may be effective. Parents were surveyed after observing a video describing a hypothetical Lyme meningitis treatment trial. Eighty-four of 102 (82%) would consent to their child participating. Parents would accept 2 additional days of symptoms (noninferiority margin) with doxycycline even if ceftriaxone hastened symptom resolution.

Constitutional Law: Abortion, Parental and Spousal Consent Requirements, Right to Privacy

ERIC Educational Resources Information Center

Long, Sharon L.; Ravenscraft, Patricia

1976-01-01

The constitutionality of the Missouri abortion statute was challenged by two physicians and Planned Parenthood of Central Missouri in the Danforth case. The Supreme Court reversed a district court decision in part, ruling that parental and spousal consent requirements are unconstitutional. For journal availability see HE 508 875. (LBH)

Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol

PubMed Central

Audrey, Suzanne; Ferrie, Joanne; Evans, Karen; Bell, Michael; Yates, Julie; Roderick, Marion; MacLeod, John; Hickman, Matthew

2018-01-01

Introduction The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures. Methods and analysis Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures. Ethics and dissemination The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested. Trial registration number ISRCTN49086105; Pre-results. PMID:29502095

Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

PubMed

Rogers, C G; Tyson, J E; Kennedy, K A; Broyles, R S; Hickman, J F

1998-04-01

The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

Implementation of a national school-based Human Papillomavirus (HPV) vaccine campaign in Fiji: knowledge, vaccine acceptability and information needs of parents.

PubMed

La Vincente, S F; Mielnik, D; Jenkins, K; Bingwor, F; Volavola, L; Marshall, H; Druavesi, P; Russell, F M; Lokuge, K; Mulholland, E K

2015-12-18

In 2008 Fiji implemented a nationwide Human Papillomavirus (HPV) vaccine campaign targeting all girls aged 9-12 years through the existing school-based immunisation program. Parents of vaccine-eligible girls were asked to provide written consent for vaccination. The purpose of this study was to describe parents' knowledge, experiences and satisfaction with the campaign, the extent to which information needs for vaccine decision-making were met, and what factors were associated with vaccine consent. Following vaccine introduction, a cross-sectional telephone survey was conducted with parents of vaccine-eligible girls from randomly selected schools, stratified by educational district. Factors related to vaccine consent were explored using Generalised Estimating Equations. There were 560 vaccine-eligible girls attending the participating 19 schools at the time of the campaign. Among these, 313 parents could be contacted, with 293 agreeing to participate (93.6%). Almost 80% of participants reported having consented to HPV vaccination (230/293, 78.5%). Reported knowledge of cervical cancer and HPV prior to the campaign was very low. Most respondents reported that they were satisfied with their access to information to make an informed decision about HPV vaccination (196/293, 66.9%). and this was very strongly associated with provision of consent. Despite their young age, the vaccine-eligible girls were often involved in the discussion and decision-making. Most consenting parents were satisfied with the campaign and their decision to vaccinate, with almost 90% indicating they would consent to future HPV vaccination. However, negative media reports about the vaccine campaign created confusion and concern. Local health staff were cited as a trusted source of information to guide decision-making. Just over half of the participants who withheld consent cited vaccine safety fears as the primary reason (23/44, 52.3%). This is the first reported experience of HPV introduction in a Pacific Island nation. In a challenging environment with limited community knowledge of HPV and cervical cancer, media controversy and a short lead-time for community education, Fiji has implemented an HPV vaccine campaign that was largely acceptable to the community and achieved a high level of participation. Community sensitisation and education is critical and should include a focus on the local health workforce and the vaccine target group.

Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali.

PubMed

Traore, Karim; Bull, Susan; Niare, Alassane; Konate, Salimata; Thera, Mahamadou A; Kwiatkowski, Dominic; Parker, Michael; Doumbo, Ogobara K

2015-06-16

Obtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers' and participants' parents' experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. It aimed to inform best practices in recruiting participants into genomic research. A qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software. Participants' parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand. This study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research.

Planned Parenthood League of Massachusetts v. Attorney General.

PubMed

1997-03-18

The Supreme Judicial Court of Massachusetts sustained a state statute which required pregnant unmarried minors to obtain the consent of both parents or a judge of the Superior Court in order to have an abortion. The court held that the state's interest in protecting the welfare of its minors and ensuring informed consent justified restrictions on a minor's constitutional right to choose an abortion. The court held unconstitutional, however, the law's requirement that the minor obtain the consent of both parents as an undue burden on the minor's due process rights.

Written Parental Consent and the Use of Incentives in a Youth Smoking Prevention Trial: A Case Study from Project SPLASH

ERIC Educational Resources Information Center

Leakey, Tricia; Lunde, Kevin B.; Koga, Karin; Glanz, Karen

2004-01-01

More Institutional Review Boards (IRBs) are requiring written parental consent in school health intervention trials. Because this requirement presents a formidable challenge in conducting large-scale research, it is vital for investigators to share effective strategies learned from completed trials. Investigators for the recently completed Project…

Legal protection of informed consent of minors.

PubMed

Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

Why parents and children consent to become involved in medical student teaching.

PubMed

Pinnock, Ralph; Weller, Jennifer; Shulruf, Boaz; Jones, Rhys; Reed, Peter; Mizutani, Satomi

2011-04-01

Clinical experience in paediatrics is essential for medical undergraduates. This is the first study, of which we are aware, to examine why children of different ages admitted acutely to hospital and their parents agree to become involved in medical student teaching. We wanted to establish whether they considered that they needed to give consent before seeing medical students, whether this was routinely sought and what influenced their decisions. Data were collected using questionnaires and semi-structured interviews of parents and children. Questionnaires were completed by 105 parents of children less than 6 years old, and 34 children between 10 years and 15 years old and their parents. Interviews were conducted with 32 children between the ages of 6 and 10 years and their parents. Most parents and children consider that they have a responsibility to teaching but must always be asked for consent. They were motivated by altruism, but fear of emotional distress or pain can lead them to refuse. Younger children may not be able to give reasons for not wanting to see a medical student but sometimes have firm views, which must be respected. Having seen a medical student previously did influence children's or parents' opinions. Most children who have seen a medical student were prepared to see students again. Medical students can be reassured that parents and children admitted acutely to a children's hospital have a positive attitude to student involvement and are prepared to help them learn clinical skills, but consent must always be obtained and the child's perspective must always be considered. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

The family v. the family court: sterilisation issues.

PubMed

Petersen, K

1992-06-01

Parents as guardians of minor children have the right and duty to give and withhold consent to medical treatment when the treatment is neither routine nor urgent. Parental authority, however, is not absolute and dwindles as the child gradually matures. In general, teenagers can give consent to medical treatment if they understand the nature and consequences of the proposed treatment. The diminution of parental authority is based on the premise that the child will eventually become autonomous. In cases where a sterilisation or hysterectomy procedure is being considered for a severely intellectually disabled teenager the question of consent is most contentious. Should this power belong to parents or the state? This paper examines some recent Family Court cases concerning this issue and also addresses questions about human rights, medical autonomy and the role of the Family Court. Finally, a proposal for an alternative means of decision-making in these cases is briefly outlined.

Effect of Nature-Activities Education Program on the Multiple Intelligence Level of Children in the Age Group of 8 to 12 Years

ERIC Educational Resources Information Center

Ceylan, Merve

2018-01-01

Research population consists of 15 children who attended a 5 week (3 days a week) nature-activities course with the consent of their parents during the summer term of 2016-2017 academic year. Participants were selected from children who had never taken part in a nature activity before. Measurement tool of this study was "Development of…

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

Commentary on "Waiting in Araf". Informed consent: issues and regulations.

PubMed

Catlin, A

1998-01-01

Children have the right to safety and appropriate consideration of their physical, emotional, and psychological needs in regards to treatment or research decisions. Parents have an equal right to be honored in their parenthood and respected for what they would want as the best thing for their child as a member of the family. When children are mature enough, they should be offered the opportunity of assenting or dissenting to research participation. Until such time, parents may make what they feel to be the best decisions. If a nurse feels that these principles are being violated, he or she should attempt to seek further clarification. In order to obtain information about an ongoing research project, it would be appropriate to contact the IRB or a member of the hospital ethics committee. In most cases, a satisfactory explanation will be found. In the rare case that patient's rights are truly being violated, the American Nurses Association Code of Ethics requires that nurses report incompetent, unethical, or illegal practices (ANA, 1994). Nurses who "whistle-blow" may or may not be protected against retaliation. Some states in the U.S. have developed laws that prohibit the discharge of an employee who reports unethical practices. One might expect that in some countries a nurse might not only endanger her position for such reporting but endanger his or her life as well. Ulusoy reports on research done on children without knowledge or consent of parents. Although this case took place long ago, it is certain that there are still countries in which informed consent is undeveloped and such practices continue. Nurses in developed countries with established consent policies can be hopeful that such activity is no longer seen here. As international collaboration in nursing research grows, nurses in developed nations can work to provide educational opportunities regarding the consent process for colleagues across the globe.

Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

PubMed Central

2012-01-01

Background Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. Findings In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. Conclusion The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. PMID:22818109

Ethical and legal constraints to children's participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial.

PubMed

Bwakura-Dangarembizi, Mutsa; Musesengwa, Rosemary; Nathoo, Kusum J; Takaidza, Patrick; Mhute, Tawanda; Vhembo, Tichaona

2012-07-20

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. In Zimbabwe the parental informed consent document for children participating in clinical research is modeled after Western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

Therapeutic misconception: hope, trust and misconception in paediatric research.

PubMed

Woods, Simon; Hagger, Lynn E; McCormack, Pauline

2014-03-01

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a 'collective' TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.

The use of reconsent in a national evaluation of adolescent reproductive health programs.

PubMed

Palen, Lori-Ann; Ashley, Olivia Silber; Jones, Sarah B; Lyons, Jeffrey D; Derecho, Azucena A; Kan, Marni L; Richmond Scott, Alicia

2012-08-01

Reconsent involves asking research participants to reaffirm their consent for study participation when there have been significant changes in the study's procedures, risks, or benefits. We described the reconsent process, identified the reconsent rate, and examined the comparability of youths enrolled via consent and reconsent in a national evaluation of adolescent reproductive health programs. Evaluation participants from five abstinence education projects (N = 2,176) and nine projects serving pregnant or parenting adolescents (N = 878) provided either parent or youth consent or reconsent to participate in the national evaluation. Participants completed surveys that included demographic characteristics; sexual intentions, norms and behaviors; and pregnancy history. Multivariate logistic regression was used to examine associations between consent status, demographic characteristics, and risk indicators. The reconsent rates in the abstinence education and pregnant or parenting samples were 45% and 58%, respectively. Participant's age was positively associated with reconsent. Hispanic adolescents (and, for abstinence education, other racial/ethnic minorities) were underrepresented among youth with reconsent. Among abstinence education study participants, risk indicators were not associated with consent status. Among pregnant or parenting teens, those who had experienced repeat pregnancy were less likely than those who had experienced only one pregnancy to have been enrolled via reconsent. Reconsent can bolster sample size but may introduce bias by missing some racial/ethnic and age-groups. Among high-risk adolescents, reconsent may also yield a sample that differs from consented samples on risk characteristics, necessitating statistical adjustments when analyzing data. Copyright © 2012 Society for Adolescent Health and Medicine. All rights reserved.

Predicting Nonresponse Bias from Teacher Ratings of Mental Health Problems in Primary School Children

ERIC Educational Resources Information Center

Stormark, Kjell Morten; Heiervang, Einar; Heimann, Mikael; Lundervold, Astri; Gillberg, Christopher

2008-01-01

The impact of nonresponse on estimates of mental health problems was examined in a prospective teacher screen in a community survey of 9,155 7-9 year olds. For 6,611 of the children, parents consented to participation in the actual study (Responders), while for 2,544 children parental consent was not obtained (Nonresponders). The teacher screen…

The impact of parental consent on the HIV testing of minors.

PubMed

Meehan, T M; Hansen, H; Klein, W C

1997-08-01

This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. Minors should have the right to consent to HIV testing.

The impact of parental consent on the HIV testing of minors.

PubMed Central

Meehan, T M; Hansen, H; Klein, W C

1997-01-01

OBJECTIVES: This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. METHODS: HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. RESULTS: The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. CONCLUSIONS: Minors should have the right to consent to HIV testing. PMID:9279271

Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

PubMed

Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J; Kodish, Eric

2006-02-20

To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

The ethics of neonatal research: An ethicist's and a parents' perspective.

PubMed

Janvier, Annie; Farlow, Barbara

2015-12-01

The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Predictors of adolescents' consent to use health records for research and results from data collection in a Swedish twin cohort.

PubMed

Ullemar, Vilhelmina; Lundholm, Cecilia; Örtqvist, Anne K; Gumpert, Clara Hellner; Anckarsäter, Henrik; Lundström, Sebastian; Almqvist, Catarina

2015-06-01

Non-random selection into a study population due to differences between consenters and non-consenters may introduce participation bias. Past investigations of factors predicting consent to collection of medical health records for research imply that age, sex, health status, and education are of importance for participation, but disagree on the direction of effects. Very little is known about influences on consent from adolescents. Two cohorts of Swedish 15-year-old twins (total n = 4,611) previously invited to the Child and Adolescent Twin Study in Sweden (CATSS) responded to a questionnaire with information on sex, individual's health, height, weight, and parental factors. The questionnaire included a question for consent to collection of medical health records. Predictors for consent were analyzed using logistic regression. Additionally, regional differences in the collection of health records of consenters were evaluated. Males were significantly less likely to consent compared to females (OR 0.74, 95% CI 0.64-0.85). The twin siblings' decision to consent was strongly associated with consent (OR 10.9, 95% CI 8.76-13.5), and individuals whose parents had responded to the original CATSS study were more likely to consent to record collection at age 15 (OR 2.2, 95% CI 1.81-2.75). Results of the subsequent collection of consenters' medical health records varied between geographical regions of Sweden. We identified several predictors for adolescents' consent to collection of their medical health records. Further selection was introduced through the subsequent record collection. Whether this will induce participation bias in future studies depends on the research questions' relationship to the identified predictors.

A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination

PubMed Central

Forster, Alice S; Cornelius, Victoria; Rockliffe, Lauren; Marlow, Laura AV; Bedford, Helen; Waller, Jo

2017-01-01

Background: Uptake of human papillomavirus (HPV) vaccination is suboptimal among some groups. We aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) of incentives to improve HPV vaccination uptake by increasing consent form return. Methods: An equal-allocation, two-arm cluster RCT design was used. We invited 60 London schools to participate. Those agreeing were randomised to either a standard invitation or incentive intervention arm, in which Year 8 girls had the chance to win a £50 shopping voucher if they returned a vaccination consent form, regardless of whether consent was provided. We collected data on school and parent participation rates and questionnaire response rates. Analyses were descriptive. Results: Six schools completed the trial and only 3% of parents opted out. The response rate was 70% for the girls’ questionnaire and 17% for the parents’. In the intervention arm, 87% of girls returned a consent form compared with 67% in the standard invitation arm. The proportion of girls whose parents gave consent for vaccination was higher in the intervention arm (76%) than the standard invitation arm (61%). Conclusions: An RCT of an incentive intervention is feasible. The intervention may improve vaccination uptake but a fully powered RCT is needed. PMID:28829766

Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

PubMed

Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

2013-01-30

Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.

Research and Legal Perspectives on the Implications of the Family Privacy Protection Act for Research and Evaluation Involving Minors.

ERIC Educational Resources Information Center

Renger, Ralph; Gotkin, Vicki; Crago, Marjorie; Shisslak, Catherine

1998-01-01

Reviews the Family Privacy Protection Act of 1995 and its potential impact on research and evaluation involving minors. Although this legislation was not passed, the issues related to both active and passive parental consent for the participation of minors in research are very much alive. (SLD)

Guidelines for medical research in children.

PubMed

Papadatos, C J

1989-01-01

Nearly everyone agrees that violations in research occur. Nobody knows how often. But if Pediatrics is to progress children must be the subjects of research carried out in an acceptable way. The following guidelines should be followed in childhood experimentation: (1) Research should not be done on children if the same investigation can be done in adults. (2) All research projects must be evaluated by ethics committees having as members lay people and investigators possessing the qualities of competence and judgement. (3) The degree of benefit from a research procedure should be assessed against the risk of disturbance, discomfort or pain. (4) Statements regarding consent are meaningless and consent is still only partially informed. Although a parental signature does not mean that consent is informed, nevertheless parental consent must still remain as a key requirement in childhood experimentation.

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health.

PubMed

Thiel, Daniel B; Platt, Tevah; Platt, Jodyn; King, Susan B; Kardia, Sharon L R

2014-04-01

Biobanks raise challenges for developing ethically sound and practicable consent policies. Biobanks comprised of dried bloodspots (DBS) left over from newborn screening, maintained for long-term storage, and potential secondary research applications are no exception. Michigan has been a leader in transforming its DBS collection, marketing its biobank of de-identified samples for health research use. The Michigan BioTrust for Health includes approximately 4 million unconsented retrospective samples collected as early as 1984 and prospective samples added since the fall of 2010 with blanket parental consent. We engaged Michigan citizens to ascertain public attitudes, knowledge, and beliefs about the BioTrust and informed consent. A convenience sampling of 393 participants from communities around the state of Michigan (oversampling for minority populations) participated in meetings addressing newborn screening, the BioTrust and informed consent, yielding quantitative and qualitative survey and discussion data. Participants affirmed the principle of voluntary informed participation in research and advocated for greater public awareness of the existence of the BioTrust. Most expressed support for the use of DBS for research and a desire for greater involvement in granting permission for research use. Opinions varied as to which specific research uses were acceptable. Participants indicated a desire for greater engagement, public awareness, and more active decision making on the part of biobank participants and parents. Diversity of opinion over which research areas were deemed acceptable problematizes the blanket consent model that currently applies to the BioTrust's prospective DBS collection and that could become the new norm for research using de-identified data under proposed changes to the Common Rule.

Differential recall of consent information and parental decisions about enrolling children in research studies.

PubMed

Boccia, Maria L; Campbell, Frances A; Goldman, Barbara D; Skinner, Martie

2009-01-01

In the present simulation research, the authors examined the relations between the type of information that low-income parents (N = 116) recalled from informed-consent materials and their hypothetical decision to enroll a child in a clinical study. The authors gave parents or guardians of Head Start children information about a medical protocol involving high risk and significant potential benefit to child participants. Differential recall of the various categories of information (procedures, benefits, risks and costs, rights, and other) showed that relative to all consent information conveyed to them, participants recalled most about procedures and least about their child's rights as a study participant. Relative to their own recall, they also recounted most about procedures, slightly more about benefits than risks, and least about research rights. The pattern of recall differed among those who agreed to enroll and those who declined. The ratio of recalled risks to benefits predicted enrollment decisions.

Making sense of adolescent decision-making: challenge and reality.

PubMed

Unguru, Yoram

2011-08-01

Few topics in pediatric bioethics are as vexing as decision-making. Decision-making in pediatrics presents challenges for children, parents, and physicians alike. The related, yet distinct, concepts of assent and consent are central to pediatric decision-making. Although informed consent is largely regarded as a worthwhile adult principle, assent has been, and continues to be, mired in debate. Controversial subjects include a meaningful definition of assent; how old children should be to assent; who should be included in the assent process; parental permission; how to resolve disputes between children and their parents; the relationship between assent and consent; the quantity and quality of information to disclose to children and their families; how much and what information children desire and need; the necessity and methods for assessing both children's understanding of disclosed information and of the assent process itself; reconciling ethical and legal attitudes toward assent; and finally, an effective, practical, and realistically applicable decision-making model.

38 CFR 14.705 - Authority to file petitions for appointment of fiduciaries in State courts.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the written consent of: (1) The beneficiary's spouse. (2) The beneficiary's adult child, parent, adult... the minor's natural or adoptive parent or parents or the person or persons occupying the relationship... over the objections of such parent or parents if they are sui juris unless the parent or parents have...

38 CFR 14.705 - Authority to file petitions for appointment of fiduciaries in State courts.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the written consent of: (1) The beneficiary's spouse. (2) The beneficiary's adult child, parent, adult... the minor's natural or adoptive parent or parents or the person or persons occupying the relationship... over the objections of such parent or parents if they are sui juris unless the parent or parents have...

38 CFR 14.705 - Authority to file petitions for appointment of fiduciaries in State courts.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the written consent of: (1) The beneficiary's spouse. (2) The beneficiary's adult child, parent, adult... the minor's natural or adoptive parent or parents or the person or persons occupying the relationship... over the objections of such parent or parents if they are sui juris unless the parent or parents have...

The Minor's Right to Consent to Medical Treatment: A Corollary of the Constitutional Right of Privacy

ERIC Educational Resources Information Center

Raitt, G. Emmett, Jr.

1975-01-01

Argues that the existing rules governing a physician's liability for treating a child without parental consent merit reconsideration because the minor possesses a fundamental constitutional right, stemming from the right of privacy, to consent to medical care. Proposes guidelines for the development of a legislative program implementing these…

[Informed consent and parental refusal for medical treatment in childhood. The threshold of medical and social tolerance. Part II].

PubMed

Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

Medical care in pediatric patients is conditional to parental consent. Parents decide the time and type of treatment they want their children to receive when they are ill. The physician should request parental consent before carrying out the most appropriate therapy. When parents refuse the treatment offered, the physician should seek alternative therapies that may be better accepted by parents and find the most beneficial treatment for children and their families. If physicians and parents are unable to agree on the best therapeutic methods, then the physician becomes involved in an ethical conflict related to the best interests of the child and parental choices. From the above posture, the following questions arise: What should the physician do when faced with this situation? Should the physician use legal measures to force parents to accept treatment? Under what conditions is it justified to force parents and when should the decision be tolerated? What is the role of the Hospital Bioethics Committee concerning this issue? This second part focuses on proposing four practical criteria to be used by the physician and Hospital Bioethics Committee when all alternative therapies and conciliatory options have been exhausted with parents and they continue to refuse treatment. The physician then has to make a decision because the child is placed at risk of harm. This decision focuses on whether there is danger to the minor arising from the decisions of parents and if such harm is avoidable. Copyright © 2015 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

Orthodontic informed consent considering information load and serial position effect.

PubMed

Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

2015-03-01

Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of "chunking." There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation. There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of "chunking" over traditional informed consent methods in terms of patient improvement in overall comprehension, treatment recall, and treatment comprehension. The treatment domain is the most affected. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Children as donors: a national study to assess procurement of organs and tissues in pediatric intensive care units.

PubMed

Siebelink, Marion J; Albers, Marcel J I J; Roodbol, Petrie F; Van de Wiel, Harry B M

2012-12-01

A shortage of size-matched organs and tissues is the key factor limiting transplantation in children. Empirical data on procurement from pediatric donors is sparse. This study investigated donor identification, parental consent, and effectuation rates, as well as adherence to the national protocol. A national retrospective cohort study was conducted in all eight Dutch pediatric intensive care units. Records of deceased children were analyzed by an independent donation officer. Seventy-four (11%) of 683 deceased children were found to be suitable for organ donation and 132 (19%) for tissue donation. Sixty-two (84%) potential organ donors had been correctly identified; the parental consent and effectuation rate was 42%. Sixty-three (48%) potential tissue donors had been correctly identified; the parental consent and effectuation rate was 27%. Correct identification increased with age (logistic regression, organs: P = .024; tissues: P = .011). Although an overall identification rate of 84% of potential organ donors may seem acceptable, the variation observed suggests room for improvement, as does the overall low rate of identification of pediatric tissue donors. Efforts to address the shortage of organs and tissues for transplantation in children should focus on identifying potential donors and on the reasons why parents do not consent. © 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.

Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

PubMed

Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

2015-12-01

Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

A Clustered Randomized Controlled Trial to Determine Impacts of the Harvest of the Month Program

ERIC Educational Resources Information Center

LaChausse, Robert G.

2017-01-01

The study purpose was to examine the impact of the Harvest of the Month (HOTM) program on fruit and vegetable (FV) consumption, FV preferences, other eating behaviors, physical activity and other variables related to healthy eating. A clustered randomized controlled trial was employed in 28 elementary schools. After parental consent was obtained,…

A qualitative study of experience of parents of adolescents who received ECT.

PubMed

Grover, Sandeep; Varadharajan, Natarajan; Avasthi, Ajit

2017-12-01

To evaluate the experience of parents of adolescents who received ECT for severe mental illness. Using qualitative methods, 6 parents of 5 adolescents were interviewed by using a self-designed semi-structured interview after the completion of ECT course. The clinicians involved in the ECT procedure, i.e., seeking informed consent and administration of ECT were not aware about the study. All the interviews were recorded and the content was analysed and themes were generated. Parents of all the 5 adolescents expressed that their children were considered for ECT only after the patient had not responded to medication and were unmanageable. Prior to ECT the treating doctors did explain to them about the ECT procedure, they were given information booklet and they were not coerced to consent for ECT. Some of the parents reported that they had dilemma prior to giving consent and were scared prior to the first ECT. However, as the clinical condition of their children improved, they felt that ECT was a good treatment. Majority of the parents felt that ECT was delayed for their children. When asked about restriction in use of ECT in children and adolescents, the parents expressed that it is important for law makers to understand the distress of the parents,when their children are acutely ill. They expressed that decision of administration of ECT must be left to the family and the treating clinicians. Parents of adolescents considered for ECT are generally satisfied with the treatment procedure. Copyright © 2017 Elsevier B.V. All rights reserved.

Key factors in children's competence to consent to clinical research.

PubMed

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-10-24

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that explaines most of to the variance in children's competence to consent, followed by intelligence. Experience with disease did not affect competence in this study, nor did other variables. Development and use of a standardized instrument for assessing children's competence to consent in drug trials: Are legally established age limits valid?, NTR3918.

Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

PubMed

Nimbalkar, Somashekhar Marutirao; Patel, Dipen Vasudev; Phatak, Ajay Gajanan

2016-01-01

Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.

Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

PubMed

Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

2015-11-09

For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children's competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.

Emerging issues in paediatric health research consent forms in Canada: working towards best practices

PubMed Central

2013-01-01

Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. PMID:23363554

Parent Knowledge and Attitudes About School-Based Hepatitis B Immunization Programs.

ERIC Educational Resources Information Center

Middleman, Amy B.; Guajardo, Andrea D.; Sunwoo, Edward; Sansaricq, Kim M.

2002-01-01

Surveyed parents of students in the Houston Independent School District to determine preferences regarding immunization clinic site and preferred consent procedures for a Hepatitis B immunization program. Results indicated a significant lack of parent knowledge regarding the Hepatitis B virus. Demographic variables influenced parents' knowledge…

Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study

PubMed Central

Voepel-Lewis, Terri; McGonegal, Maureen; Levine, Robert

2011-01-01

Standard written methods of presenting research information may be difficult for many parents and children to understand. This pilot study was designed to examine the use of a novel prototype interactive consent program for describing a hypothetical pediatric asthma trial to parents and children. Parents and children were interviewed to examine their baseline understanding of key elements of a clinical trial, eg, randomization, placebo, and blinding. Subjects then reviewed age-appropriate versions of an interactive computer program describing an asthma trial, and their understanding of key research concepts was again tested along with their understanding of the details of the trial. Parents and children also completed surveys to examine their perceptions and satisfaction with the program. Both parents and children demonstrated improved understanding of key research concepts following administration of the consent program. For example, the percentage of parents and children who could correctly define the terms clinical trials and placebo improved from 60% to 80%, and 80% to 100% among parents and 25% to 50% and 0% to 50% among children, respectively, following review of the interactive programs. Parents and children's overall understanding of the details of the asthma trial were 14.2±0.84 and 9.25±4.9 (0–15 scale, where 15 is complete understanding), respectively. Results also suggest that the interactive programs were easy to use and facilitated understanding of the clinical trial among parents and children. Interactive media may offer an effective means of presenting understandable information to parents and children regarding participation in clinical trials. Further work to examine this novel approach appears warranted. PMID:21803924

Understanding how different recruitment strategies impact parent engagement with an iPad-based intervention to provide personalized information about adolescent vaccines.

PubMed

Dempsey, Amanda F; Maertens, Julie; Beaty, Brenda L; O'Leary, Sean T

2015-05-01

Inadequate provider time for addressing parents' questions and concerns about adolescent vaccines is a barrier to vaccine utilization. We sought to determine how different recruitment strategies impact the degree of engagement with an intervention that provided this information via an iPad placed in a clinical setting. We provided to three pediatric practices in the Denver area the "Teen VaxScene" web site that generates individually customized information for parents about adolescent vaccines. Three recruitment strategies were assessed for their impact on parental use of the intervention as follows: passive recruitment using posters to advertise a "kiosk" version of the intervention; posters plus a $10 incentive for using the kiosk; and posters plus a $10 incentive plus decoupling the iPad from the kiosks to enable "roving." We assessed the engagement with the intervention at multiple levels including log in, consent, and completion of a baseline survey and viewing individually tailored web pages. Surveys were used to assess barriers to using the intervention. During the 14-month study period, 693 people had contact with the iPad, 199 consented, and 48 completed the survey to enable creation of tailored content; and 42 used the tailored site. Five times as many parents (n = 40) consented to participation during the 2 months when the intervention was "roving" than during the 10-month "passive" recruitment period. Engagement with the tailored material was low, with most users viewing only the "table of contents" pages. Utilizers and nonutilizers of the intervention had similar demographic characteristics. Enabling the iPad to "rove" in the clinic greatly increased the proportion of parents consenting to use the intervention. However, meaningful engagement with the material was low. Further research is needed to understand the most effective and time efficient ways to provide vaccine-related educational information to parents of adolescents. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Blood Transfusion in Children: The Refusal of Jehovah's Witness Parents'.

PubMed

Conti, Adelaide; Capasso, Emanuele; Casella, Claudia; Fedeli, Piergiorgio; Salzano, Francesco Antonio; Policino, Fabio; Terracciano, Lucia; Delbon, Paola

2018-01-01

In Italy, both parents have parental responsibility; as a general principle they have the power to give or withhold consent to medical procedures on their children, including consent for blood transfusion; however these rights are not absolute and exist only to promote the welfare of children. The Authors discuss ethical and legal framework for Jehovah's Witness parents' refusal of blood transfusion in Italy. They searched national judgments concerning Jehovah's Witness parents' refusal of blood transfusion - and related comments - in national legal databases and national legal journals, and literature on medical literature databases. In the case of Jehovah's Witness parents' refusal of blood transfusion for their child, Italian Courts adopt measures that prevents the parents from exercise their parental responsibility not in the child's best interest. In the event that refusal by the parents, outside of emergency situations, exposes the child's health to serious risk, health workers must proceed by notifying the competent authority, according also to the Italian Code of Medical Ethics. When the patient is a minor, the child's best interest always come first.

Planned Parenthood of Southeastern Pennsylvania v. Casey.

PubMed

1990-08-24

Pennsylvania amended its abortion statute to include a mandatory 24-hour waiting period, parental consent, spousal notification, physician-only disclosure requirements, and various other reporting provisions. Planned Parenthood filed suit, alleging infringement of a woman's right to choose an abortion. The federal district court held the amendments to be unconstitutional. First, the 24-hour waiting period arbitrarily increased cost and risk of delay by requiring two trips to the abortion clinic, without furthering the state's interest in maternal health. Secondly, the amendment's requirement that only the physician, and not an agent, may disclose information relevant to informed consent unreasonably insisted that only a physician is competent to provide the information. The parental consent and spousal notification requirements imposed unconstitutional burdens on the woman's decision.

Hope and persuasion by physicians during informed consent.

PubMed

Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

2014-10-10

To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

Hope and Persuasion by Physicians During Informed Consent

PubMed Central

Miller, Victoria A.; Cousino, Melissa; Leek, Angela C.; Kodish, Eric D.

2014-01-01

Purpose To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Patients and Methods Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. Results The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Conclusion Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. PMID:25199753

A Randomized Controlled Trial of an Electronic Informed Consent Process

PubMed Central

Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

2018-01-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. PMID:25747685

Predictors of body mass index in female parents whose children participate in a competitive, creative, problem-solving program.

PubMed

Moustaid-Moussa, Naima; Costello, Carol A; Greer, Betty P; Spence, Marsha; Fitzhugh, Eugene; Muenchen, Robert; Kalupahana, Nishan S

2012-01-01

Recent findings from our research indicate that children participating in a creative afterschool program exhibit overall healthier lifestyle practices compared to the average US pediatric population. This observation led us to investigate the prevalence of overweight/obesity and lifestyle practices of their parents. To determine the strongest predictors of weight status for female parents whose children were participating in such creative afterschool program. Surveyed subjects were parents of children who competed in the 2008 and 2009 Destination ImagiNation(®) Global Finals in Knoxville, Tennessee. A total of 4,608 children participated in data collection, with parental consent. For the combined 2 years, 1,118 parents, 87% of whom were females (n=1,032) completed online questionnaires, which were based on the Behavioral Risk Factor Surveillance System and included self-reported height, weight, dietary intake, physical activity, and socioeconomic status. The majority of this population was white, and less than 5% were African American or Hispanic. We report here results obtained for the female parents. Only 45.2% of these female parents were overweight/obese, compared to a national average of 64.1% reported by the National Health Nutrition Examination Surveys for 2007-2008. Furthermore, this population was significantly more physically active compared to national average. Most parents (76%) had completed a college degree and reported high incomes. Parents with the lowest income were the most obese in this population. Finally, we found a significant association between parent and child weight status. These studies demonstrate that female parents of children who have healthy lifestyles were physically active, which likely accounts for the parents' lower overweight/obesity rates. In addition to physical activity, income and percentage of calories from fat were all predictors of weight status.

Communicating and understanding the purpose of pediatric phase I cancer trials.

PubMed

Cousino, Melissa K; Zyzanski, Stephen J; Yamokoski, Amy D; Hazen, Rebecca A; Baker, Justin N; Noll, Robert B; Rheingold, Susan R; Geyer, J Russell; Alexander, Stewart C; Drotar, Dennis; Kodish, Eric D

2012-12-10

Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies. In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I-related concepts during the ICC. Parent interviews were analyzed to determine understanding. The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs. Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

PubMed

Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

2015-01-01

To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

34 CFR 300.9 - Consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child is initially provided special education and related services, the public agency is not required to...

34 CFR 300.9 - Consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child... amend the child's education records to remove any references to the child's receipt of special education...

Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

PubMed Central

Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

2015-01-01

Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

PubMed

Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

2017-09-02

Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

Predictors of body mass index in female parents whose children participate in a competitive, creative, problem-solving program

PubMed Central

Moustaid-Moussa, Naima; Costello, Carol A.; Greer, Betty P.; Spence, Marsha; Fitzhugh, Eugene; Muenchen, Robert; Kalupahana, Nishan S.

2012-01-01

Background Recent findings from our research indicate that children participating in a creative afterschool program exhibit overall healthier lifestyle practices compared to the average US pediatric population. This observation led us to investigate the prevalence of overweight/obesity and lifestyle practices of their parents. Objective To determine the strongest predictors of weight status for female parents whose children were participating in such creative afterschool program. Design Surveyed subjects were parents of children who competed in the 2008 and 2009 Destination ImagiNation® Global Finals in Knoxville, Tennessee. A total of 4,608 children participated in data collection, with parental consent. For the combined 2 years, 1,118 parents, 87% of whom were females (n=1,032) completed online questionnaires, which were based on the Behavioral Risk Factor Surveillance System and included self-reported height, weight, dietary intake, physical activity, and socioeconomic status. The majority of this population was white, and less than 5% were African American or Hispanic. Results We report here results obtained for the female parents. Only 45.2% of these female parents were overweight/obese, compared to a national average of 64.1% reported by the National Health Nutrition Examination Surveys for 2007—2008. Furthermore, this population was significantly more physically active compared to national average. Most parents (76%) had completed a college degree and reported high incomes. Parents with the lowest income were the most obese in this population. Finally, we found a significant association between parent and child weight status. Conclusions These studies demonstrate that female parents of children who have healthy lifestyles were physically active, which likely accounts for the parents’ lower overweight/obesity rates. In addition to physical activity, income and percentage of calories from fat were all predictors of weight status. PMID:22912600

Cosmetic surgery in teenagers: to do or not to do.

PubMed

Singh, Kuldeep

2015-01-01

The media makes it out to be a big story that teens are getting cosmetic surgery in larger numbers than ever. However, this is far from the truth. Yearly data, is increasingly showing a reduction in the percentage, as well as absolute numbers of these surgeries. Only, very essential surgery should be done for teenagers. The consult should be done in the presence of a parent, and even if the teen is above legal consenting age, parental supervision is still needed. A cooling off period, informed consent under parental supervision, and a time to rethink is essential. If a problem is severe enough to cause psychological problems, a psychologist can help in arriving at a decision.

A School-Located Vaccination Adolescent Pilot Initiative in Chicago: Lessons Learned.

PubMed

Caskey, Rachel N; Macario, Everly; Johnson, Daniel C; Hamlish, Tamara; Alexander, Kenneth A

2013-09-01

Many adolescents underutilize preventive services and are underimmunized. To promote medical homes and increase immunization rates, we conceptualized and implemented a 3-year, 8-school pilot school-located vaccination collaborative program. We sought community, parent, and school nurse input the year prior to implementation. We selected schools with predominantly Medicaid-enrolled or Medicaid-eligible students to receive Vaccines For Children stock vaccines. Nurses employed by a mass immunizer delivered these vaccines at participating schools 3 times a year. Over 3 years, we delivered approximately 1800 vaccines at schools. School administrators, health centers, and neighboring private physicians generally welcomed the program. Parents did not express overt concerns about school-located vaccination. School nurses were not able to participate because of multiple school assignments. Obtaining parental consent via backpack mail was an inefficient process, and classroom incentives did not increase consent form return rate. The influenza vaccine had the most prolific uptake. The optimal time for administering vaccines was during regular school hours. Although school-located vaccination for adolescents is feasible, this is a paradigm shift for community members and thus accompanies challenges in implementation. High principal or school personnel turnover led to a consequent lack of institutional memory. It was difficult to communicate directly with parents. Because we were uncertain about the proportion of parents who received consent forms, we are exploring Internet-based and back-to-school registration options for making the consent form distribution and return process more rigorous. Securing an immunization champion at each school helped the immunization processes. Identifying a financially sustainable school-located vaccination model is critical for national expansion of school-located vaccination. © The Author 2013. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Parental acceptance of pediatric behavior management techniques: a comparative study.

PubMed

Elango, I; Baweja, D K; Shivaprakash, P K

2012-01-01

To evaluate and compare the attitude toward behavior techniques among parents of healthy and special children in Indian subpopulation. Parents of healthy (Group A) and special children (Group B) watched videotape vignette of 10 behavior management techniques (BMTs) in groups and rated them using Visual Analog Scale (VAS). Group B parents were subgrouped as: Group B 1 (34 parents of medically compromised children), Group B 2 (34 parents of physically compromised children), and Group B 3 (34 parents of children with neuropathological disorders). Both Group A and Group B subjects judged all techniques as "acceptable." Group B parents were less accepting to techniques than Group A parents, except live modeling. Contingent escape and live modeling were the first ranked techniques in Group A and Group B parents, respectively. Voice control (VC) and hand-over-mouth exercise (HOM) were the least accepted techniques in both groups. Parents with low income and less education were more receptive to the techniques studied. A total of 25.49% of parents in each group did not consent to the use of HOM. Factors such as having a disabled child, low income, and less education influenced parental acceptability. HOM should be used with great caution and clinicians should approach the issue of informed consent on an individual basis.

Focusing on flu: Parent perspectives on school-located immunization programs for influenza vaccine.

PubMed

Middleman, Amy B; Short, Mary B; Doak, Jean S

2012-10-01

School-located immunization programs (SLIP) will only be successful if parents consent to their children's participation. It is critical to understand parent perspectives regarding the factors that make them more or less likely to provide that consent. Organizations creating SLIPs will be able to capitalize on the aspects of SLIPs that parents appreciate, and address and correct issues that may give rise to parent concerns. This study involved five focus groups among the parents of school students in a large, urban school district. Findings highlight the broad range of concepts important to parents when considering participation in a SLIP. The safety and trust issues regarding vaccines in general that are so important to parents are also important to parents when considering participation in a SLIP. Effective communication strategies that include assurances regarding tracking of information and the competence and experience of immunizers will be helpful when addressing parents regarding SLIPs. In addition, parents were very cognizant of and positive regarding the public health benefits associated with SLIPs. Further study among larger populations of parents will further refine these ideas and aid in the development of successful influenza vaccine SLIPs that directly address and communicate with parents about the issues most important to them.

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents.

PubMed

Knopf, Amelia S; Gilbert, Amy Lewis; Zimet, Gregory D; Kapogiannis, Bill G; Hosek, Sybil G; Fortenberry, J Dennis; Ott, Mary A

2017-01-01

Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

Minors' rights to consent to treatment: navigating the complexity of State laws.

PubMed

Vukadinovich, David M

2004-01-01

State laws recognize that a competent adult patient has the right to consent to or refuse medical treatment. While the law is clear with regard to the right of competent adults, state statutes are more complicated when the patient is a minor. While the law should, and does, attempt to balance the rights and obligations of parents and guardians against the access and privacy rights of minors, complicated state statutory schemes often fail to simultaneously address those contrasting goals in a consistent and uniform manner. The result is a confusing set of seemingly arbitrary and sometimes conflicting provisions that require the detailed attention of healthcare providers to ensure legal compliance. With the aim of helping healthcare practitioners meet their legal obligations, this Article examines state laws governing minor's consent rights byfocusing on the instances in which a minor's parent, guardian, or other authorized adult is permitted to consent to treatment on behalf of a minor and the instances in which a minor is authorized to act independent of adult intervention.

Barriers and facilitators to uptake of the school-based HPV vaccination programme in an ethnically diverse group of young women.

PubMed

Batista Ferrer, Harriet; Trotter, Caroline L; Hickman, Matthew; Audrey, Suzanne

2016-09-01

To identify the barriers and facilitators to uptake of the HPV vaccine in an ethnically diverse group of young women in the south west of England. Three school-based vaccination sessions were observed. Twenty-three young women aged 12 to 13 years, and six key informants, were interviewed between October 2012 and July 2013. Data were analysed using thematic analysis and the Framework method for data management. The priority given to preventing cervical cancer in this age group influenced whether young women received the HPV vaccine. Access could be affected by differing levels of commitment by school staff, school nurses, parents and young women to ensure parental consent forms were returned. Beliefs and values, particularly relevant to minority ethnic groups, in relation to adolescent sexual activity may affect uptake. Literacy and language difficulties undermine informed consent and may prevent vaccination. The school-based HPV vaccination programme successfully reaches the majority of young women. However, responsibility for key aspects remain unresolved which can affect delivery and prevent uptake for some groups. A multi-faceted approach, targeting appropriate levels of the socio-ecological model, is required to address procedures for consent and cultural and literacy barriers faced by minority ethnic groups, increase uptake and reduce inequalities. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health.

A randomized controlled trial of an electronic informed consent process.

PubMed

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

34 CFR 300.300 - Parental consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the parent of the child; (ii) The rights of the parents of the child have been terminated in... REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH...) The public agency proposing to conduct an initial evaluation to determine if a child qualifies as a...

Parental refusal of life-saving treatments for adolescents: Chinese familism in medical decision-making re-visited.

PubMed

Hui, Edwin

2008-06-01

This paper reports two cases in Hong Kong involving two native Chinese adolescent cancer patients (APs) who were denied their rights to consent to necessary treatments refused by their parents, resulting in serious harm. We argue that the dynamics of the 'AP-physician-family-relationship' and the dominant role Chinese families play in medical decision-making (MDM) are best understood in terms of the tendency to hierarchy and parental authoritarianism in traditional Confucianism. This ethic has been confirmed and endorsed by various Chinese writers from Mainland China and Hong Kong. Rather than giving an unqualified endorsement to this ethic, based more on cultural sentimentalism than rational moral reasoning, we warn that a strong familism in MDM, which deprives 'weak' family members of rights, represents the less desirable elements of this tradition, against which healthcare professionals working in this cultural milieu need to safeguard. Specifically for APs, we suggest that parental authority and family integrity should be re-interpreted in terms of parental responsibility and the enhancement of children's interests respectively, as done in the West. This implies that when parents refuse to consent to necessary treatment and deny their adolescent children's right to consent, doctors, as the only remaining advocates of the APs' interest, have the duty to inform the state, which can override parental refusal to enable the doctors to fulfill their professional and moral obligations. In so doing the state exercises its 'parens patriae' power to defend the defenseless in society and the integrity of the medical profession.

Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions.

PubMed

Finigan-Carr, Nadine M; Copeland-Linder, Nikeea; Haynie, Denise L; Cheng, Tina L

2014-01-01

Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11-13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families ( N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation.

Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions

PubMed Central

Finigan-Carr, Nadine M.; Copeland-Linder, Nikeea; Haynie, Denise L.; Cheng, Tina L.

2016-01-01

Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11–13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families (N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation. PMID:27122960

8 CFR 204.304 - Improper inducement prohibited.

Code of Federal Regulations, 2013 CFR

2013-01-01

... influence any decision concerning: (1) The placement of a child for adoption; (2) The consent of a parent, a... adoption; or (4) The performance by the child's parent or parents of any act that makes the child a... with the birth or any illness of the child; (4) Counseling services for a parent or a child for a...

8 CFR 204.304 - Improper inducement prohibited.

Code of Federal Regulations, 2014 CFR

2014-01-01

... influence any decision concerning: (1) The placement of a child for adoption; (2) The consent of a parent, a... adoption; or (4) The performance by the child's parent or parents of any act that makes the child a... with the birth or any illness of the child; (4) Counseling services for a parent or a child for a...

8 CFR 204.304 - Improper inducement prohibited.

Code of Federal Regulations, 2012 CFR

2012-01-01

... influence any decision concerning: (1) The placement of a child for adoption; (2) The consent of a parent, a... adoption; or (4) The performance by the child's parent or parents of any act that makes the child a... with the birth or any illness of the child; (4) Counseling services for a parent or a child for a...

Adolescents and consent to treatment.

PubMed

Dickens, B M; Cook, R J

2005-05-01

Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

Condom availability in the schools: lessons from the courtroom.

PubMed

Mahler, K

1996-01-01

The Massachusetts Supreme Judicial Court unanimously supported the condom availability program of the Falmouth School District. The program allows students in grades 7-12 full access to condoms without prior parental consent. Before the junior high students can receive counseling, however, they must first undergo counseling. Like the high school students (who have access to counseling, but do not require it before receiving condoms), junior high school students also have access to informational pamphlets. The court rejected the parents' claims that the program infringed on their rights as parents since students are free to decline to participate in the program and the parents are free to tell their children not to participate. In January 1996, the US Supreme Court refused to review this case and provided no comment or recorded dissent. On the other hand, in 1993, the New York appellate court, in a 3-2 decision, found that the condom availability program of New York City public schools coerced parents to surrender their rights to raise their children without undue interference from the state. When New York City later offered parents an opt-out, fewer than 1% of parents of high school students selected it. A clear history of legal precedent supports a minor's right to consent to the receipt of medical services related to sexuality and reproductive health. There is currently a challenge to the condom availability program in the Philadelphia public schools, which offers an opt-out provision for parents who do not want their children to participate in the program. The challenge revolves around the supposition that parental consent is needed for some medical services, in this case provision of condoms. What makes this case unique is that parents who support the condom program are parties in the lawsuit. The unpredictability of school districts and local governing bodies do not guarantee the success of implementing comprehensive school-based AIDS education programs. Some parents and conservative groups will continue to fight condom availability programs.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

PubMed

Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

2012-08-21

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

Information Parents Must Know about Online Privacy.

ERIC Educational Resources Information Center

Markell, Ginny

2000-01-01

Presents four tips to help parents monitor whether website operators are complying with the 1988 Children's Online Privacy Protection Act: look for privacy policies on children's websites; determine if they ask for parental consent to collect personal information; regularly monitor information being sent to children; and determine if web operators…

7 CFR 215.13a - Determining eligibility for free milk in child-care institutions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Medicaid and/or SCHIP, unless parents decline. Children's free milk eligibility information only may be... enroll children in Medicaid and SCHIP; and (ii) Parents/guardians are notified that their eligibility... permitted access to children's eligibility information without parent/guardian consent, the State agency or...

7 CFR 215.13a - Determining eligibility for free milk in child-care institutions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... children's free milk eligibility information to Medicaid and/or SCHIP, unless parents decline. Children's... and the child care institution so elect, the parent/guardian does not decline to have their... information without parent/guardian consent, the State agency or child care institution, as appropriate, must...

7 CFR 215.13a - Determining eligibility for free milk in child-care institutions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... children's free milk eligibility information to Medicaid and/or SCHIP, unless parents decline. Children's... and the child care institution so elect, the parent/guardian does not decline to have their... information without parent/guardian consent, the State agency or child care institution, as appropriate, must...

7 CFR 215.13a - Determining eligibility for free milk in child-care institutions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... children's free milk eligibility information to Medicaid and/or SCHIP, unless parents decline. Children's... and the child care institution so elect, the parent/guardian does not decline to have their... information without parent/guardian consent, the State agency or child care institution, as appropriate, must...

Effective Group Work for Elementary School-Age Children Whose Parents Are Divorcing.

ERIC Educational Resources Information Center

DeLucia-Waack, Janice; Gerrity, Deborah

2001-01-01

Parental divorce is the issue of most concern for elementary school children. This article describes interventions for children-of-divorce groups for elementary school children. Suggests guidelines related to goal setting; securing agency and parental consent; leadership planning; recruitment, screening, and selection of members; group member…

A Guide to the Multifactored Evaluation (MFE).

ERIC Educational Resources Information Center

Ohio Coalition for the Education of Children with Disabilities, Marion.

This guide provides Ohio parents of children with disabilities with information on multifactored evaluations. It begins by discussing the Intervention Assistance Team and what occurs at the assistance team meeting. It also explains that to begin the multifactored evaluation process, the parent must complete a "Request for Parent Consent for…

32 CFR 776.27 - Conflict of interests: Prohibited transactions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... giving the covered attorney or a person related to the covered attorney as parent, child, sibling, or... attorney who is related as parent, child, sibling, or spouse to the covered attorney, except upon consent...

Legal responsibilities when fitting minors with contact lenses.

PubMed

Harris, M G

2000-02-01

Practitioners must understand their legal responsibilities in fitting minors with contact lenses, which include informed consent, contractual obligations, and the Statute of Limitations. Minors are children and teenagers who have not yet reached voting age in their state--generally 18 years of age. Informed consent requires permission from the patient before a practitioner performs any treatment. For these young people, this consent generally can only be given by a parent or legal guardian. Minors can repudiate contracts made with them; therefore, the contractual obligation to pay for a contact lens fitting should be established with a parent or legal guardian. In most states, minors have additional time beyond the usual Statute of Limitations to bring a lawsuit. If practitioners recognize their legal responsibilities in caring for these special patients, fitting youngsters with contact lenses can be a rewarding part of practice.

Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial.

PubMed

Nieminen, Heta; Syrjänen, Ritva K; Puumalainen, Taneli; Sirén, Päivi; Palmu, Arto A

2015-07-17

The Finnish Invasive Pneumococcal disease (FinIP) vaccine trial was a nationwide cluster-randomised double-blind trial designed to demonstrate the effectiveness of pneumococcal conjugate vaccine in vaccinated children and indirect effects in unvaccinated populations. Together with the parallel carriage/AOM trial, over 47,000 children were enrolled, 52% of the initial target. We conducted a questionnaire study to find out which factors affected parents' decision on their child's study participation. A questionnaire designed to evaluate parents' attitudes to vaccine trial participation in general and the FinIP trial in particular was mailed after the trial enrolment period had ended to parents of randomly selected children: 1484 who participated in the trial and 1485 who did not participate. Altogether 1438 parents (48%) responded to the questionnaire. The response rate was higher among FinIP participants (65%, 965/1484) than among FinIP non-participants (32%, 473/1485). The two most important reasons for giving consent to the FinIP trial were the potential benefit of immunisation against pneumococcal diseases (75% of consenters) and the promotion of the common good and public health (11%). The reasons reported as most important for declining consent were suspicions of vaccine safety (36%) and the double-blind trial design (12%). Up to 65% of the non-consenters declared that drug and vaccine trials should not be conducted in children at all. The expected health benefit for the child was by far the most important reason for consenting to the vaccine trial. Safety concern was the main reason for decline. Importance and necessity of clinical drug and vaccine trials among children and the rationale of the blinded studies should be thoroughly explained to the public. This may increase participation in future vaccine trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

25 CFR 43.16 - Copy to be provided to parents or eligible students.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Copy to be provided to parents or eligible students. 43... AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.16 Copy to be provided to parents or eligible students. Where the consent of a parent or eligible student is required under this part for the release of...

Autism, intellectual disability, and a challenge to our understanding of proxy consent.

PubMed

Graber, Abraham

2017-06-01

This paper focuses on a hypothetical case that represents an intervention request familiar to those who work with individuals with intellectual disability. Stacy has autism and moderate intellectual disability. Her parents have requested treatment for her hand flapping. Stacy is not competent to make her own treatment decisions; proxy consent is required. There are three primary justifications for proxy consent: the right to an open future, substituted judgment, and the best interest standard. The right to an open future justifies proxy consent on the assumption of future autonomy whereas substituted judgment justifies proxy consent via reference to past autonomy. Neither applies. Stacy has not been, nor will she be, competent to make her own treatment decisions. The best interest standard justifies proxy consent on the grounds of beneficence. It is unlikely that hand flapping harms Stacy. None of the three primary means of justifying proxy consent apply to Stacy's case.

A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock

PubMed Central

O’Hara, Caitlin B; Canter, Ruth R; Mouncey, Paul R; Carter, Anjali; Jones, Nicola; Nadel, Simon; Peters, Mark J; Lyttle, Mark D; Harrison, David A; Rowan, Kathryn M; Inwald, David; Woolfall, Kerry

2018-01-01

Objective The Fluids in Shock (FiSh) Trial proposes to evaluate whether restrictive fluid bolus therapy (10 mL/kg) is more beneficial than current recommended practice (20 mL/kg) in the resuscitation of children with septic shock in the UK. This qualitative feasibility study aimed to explore acceptability of the FiSh Trial, including research without prior consent (RWPC), potential barriers to recruitment and participant information for a pilot trial. Design Qualitative interview study involving parents of children who had presented to a UK emergency department or been admitted to a paediatric intensive care unit with severe infection in the previous 3 years. Participants Twenty-one parents (seven bereaved) were interviewed 16 (median) months since their child’s hospital admission (range: 1–41). Results All parents said they would have provided consent for the use of their child’s data in the FiSh Trial. The majority were unfamiliar with RWPC, yet supported its use. Parents were initially concerned about the change from currently recommended treatment, yet were reassured by explanations of the current evidence base, fluid bolus therapy and monitoring procedures. Parents made recommendations about the timing of the research discussion and content of participant information. Bereaved parents stated that recruiters should not discuss research immediately after a child’s death, but supported a personalised postal ‘opt-out’ approach to consent. Conclusions Findings show that parents whose child has experienced severe infection supported the proposed FiSh Trial, including the use of RWPC. Parents’ views informed the development of the pilot trial protocol and site staff training. Trial registration number ISRCTN15244462—results. PMID:28847877

34 CFR 303.404 - Parent consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... obtained before— (1) Conducting the initial evaluation and assessment of a child under § 303.322; and (2... the child will not be able to receive the evaluation and assessment or services unless consent is... of the Act (34 CFR 300.571) and 34 CFR part 99 (Family Educational Rights and Privacy), both of which...

Parental Intentions to Enroll Children in a Voluntary Expanded Newborn Screening Program

PubMed Central

Paquin, Ryan S.; Peay, Holly L.; Gehtland, Lisa M.; Lewis, Megan A.; Bailey, Donald B.

2016-01-01

Background and Objectives Nearly all babies in the United States are tested at birth for rare, serious, and treatable disorders through mandatory state newborn screening (NBS). Recently, there have been calls for an expanded, voluntary model to facilitate early diagnosis and treatment of a wider range of disorders. We applied the reasoned action framework to examine parental intentions to participate in voluntary expanded screening. Methods We recruited a national cohort of recent and expectant parents living in the U.S. who completed a self-administered online survey (N = 1,001). Using a mixed-level fractional factorial experiment, we studied parental participation intentions and preferences for timing of consent, cost, consent format, and testing options. Results We conducted a hierarchical regression analysis assessing parental intentions to participate in voluntary expanded NBS. Attitudes, perceived normative influence, and perceived behavioral control explained substantial variance in intention, with perceived normative influence emerging as the strongest predictor. We found no evidence that the manipulated program features altered mean levels of intention, but timing of parental permission, cost, and permission format moderated the relative importance of reasoned action constructs on intention. Conclusion Program design features may impact the psychological mechanisms underlying parental decision making for voluntary expanded screening. These results have important implications for parent education, outreach, and informed parental permission procedures. PMID:27526258

Community perspectives on research consent involving vulnerable children in Western Kenya.

PubMed

Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

2012-10-01

Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

Community Perspectives on Research Consent Involving Vulnerable Children in Western Kenya

PubMed Central

Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

2013-01-01

Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent. PMID:23086047

75 FR 38104 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... 2 1.5 Guide (participation in focus group). Parents of boys and girls, ages 11 to Online Survey E... respondents respondent (in hours) Youths ages 11 to 18 and parents of Focus Group Screening 576 2 5/60 boys and girls, ages 11 to 18. Instrument for Youth and Script for Obtaining Verbal Consent from Parent...

Adolescent Health Care Decision Making: The Law and Public Policy.

ERIC Educational Resources Information Center

Gittler, Josephine; And Others

A large and complicated body of law deals primarily with required parental involvement in health care decisions concerning adolescent children. Addressing that body of legislation, Part 1 of this two-part background paper focuses on a survey of laws requiring parental consent to health services for minors or parental notification of a minor's…

Parent perspectives on information about late effects of childhood cancer treatment and their role in initial treatment decision making.

PubMed

Greenzang, Katie A; Dauti, Angela; Mack, Jennifer W

2018-06-01

Though most childhood cancer survivors experience late effects of treatment, we know little about parent preferences for late effects information during therapy, or how parents weigh late effects when making treatment decisions. Our objective was to explore how parents of children with cancer consider late effects in initial treatment decision making and during active cancer treatment. Semistructured interviews were conducted with 12 parents of children with cancer who were actively receiving treatment at Dana-Farber/Boston Children's Cancer and Blood Disorders Center. Interviews were audio-recorded, transcribed verbatim, and qualitatively analyzed using thematic analysis. Ten of 12 parents reported that they had to decide between two or more treatment options for their child's cancer. Of those, 50% (5/10) considered late effects to be an important factor in their decision making. Most parents wanted early and detailed information about their child's risk of late effects to make treatment decisions and to feel prepared for the future. However, a few parents felt too overwhelmed to focus on late effects at diagnosis. While many recalled extensive late effects information in informed consent discussions, some parents felt these issues were minimally addressed. Parents desire detailed information about late effects to make informed treatment decisions and prepare for the future. Despite the role of late effects in treatment decision making, some parents feel that late effects are either inadequately addressed or too overwhelming to process at diagnosis. Parents may benefit from early assessment of their information needs and a return to these issues over time. © 2018 Wiley Periodicals, Inc.

Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

ERIC Educational Resources Information Center

King, Cheryl A.; Kramer, Anne C.

2008-01-01

Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

Parental and youth understanding of the informed consent process for pediatric endoscopy.

PubMed

Jubbal, Kevin; Chun, Stanford; Chang, Jeremy; Zhang, Sherry; Terrones, Laura; Huang, Jeannie S

2015-06-01

Informed consent (IC) is an essential communication between patient/representative and physician that acknowledges patient autonomy; assent is the equivalent process performed between youth and physician. For clinical procedures involving youth, only the IC process between guardian/parent and physician is required to be performed. Nevertheless, experts recommend that youth undergo assent whenever possible. In the present study, we explored both parental and youth understanding of required IC elements in IC discussions before pediatric endoscopy. Following signing of IC documents on the day of endoscopy at a tertiary care academic medical center, youth and their parents underwent structured interviews to assess comprehension of key elements of the IC process. A total of 88 children and adolescents and their parents were evaluated. Two youth and 12 parents demonstrated comprehensive understanding of key IC elements for pediatric endoscopy. Suboptimal youth understanding was demonstrated for nature of the procedure (25% with adequate understanding) and related risks (17%), and alternatives (14%) to the procedure. Suboptimal parental understanding was demonstrated for procedure alternatives (24%). Youth overall understanding of IC varied by age, whereas parental global understanding of IC varied by physician. Understanding of IC performed for pediatric endoscopy could be improved in both parents and youth. Our findings suggest that interventions targeting parents, youth, and physicians may be helpful. Further study is needed to determine whether our findings are representative of IC understanding at other pediatric endoscopy centers.

State secrets: access to information under the Human Reproductive Technology Act 1991 (WA).

PubMed

Tarrant, Stella

2002-02-01

Many Australian children have a biological father who gave his sperm so that the child's mother could conceive and raise them. Many of these children, and their parent(s), do not know who that biological father is. However, some want to know. The article examines the Western Australian law on access to information about the identity of parties in these arrangements. It is argued that there is an implied right to access identifying information where all parties consent to the exchange of information; that this right has been ignored in official and medical practice and opportunities for good record-keeping missed; and that the current law allows a parent to give consent to the exchange of identifying information on behalf of their child at any time after the child is conceived.

On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

PubMed

Kara, Mahmut A; Aksoy, Sahin

2006-09-01

Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

Changes in Children's Behavior and Costs for Service Use Associated with Parents' Response to Treatment for Dysthymia

ERIC Educational Resources Information Center

Byrne, Carolyn; Browne, Gina; Roberts, Jacqueline; Mills, Michael; Bell, Barbara; Gafni, Amiram; Jamieson, Ellen; Webb, Michelle

2006-01-01

Objective: This study examined differences in children's behavior and expenditures for health and social services used when their parents with dysthymia did or did not respond to antidepressant therapy. Method: Children ages 4 to 16 years of consenting parents enrolled in a treatment trial for dysthymia who did and did not respond to treatment…

Assessing children’s competence to consent in research by a standardized tool: a validity study

PubMed Central

2012-01-01

Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children’s competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies. PMID:23009102

20 CFR 401.100 - Disclosure of records with the written consent of the subject of the record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION Disclosure of Official Records and.... Except as permitted by the Privacy Act and the regulations in this part, or when required by the FOIA, we... record is to be disclosed. (d) A parent or guardian of a minor is not authorized to give written consent...

20 CFR 401.100 - Disclosure of records with the written consent of the subject of the record.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION Disclosure of Official Records and.... Except as permitted by the Privacy Act and the regulations in this part, or when required by the FOIA, we... record is to be disclosed. (d) A parent or guardian of a minor is not authorized to give written consent...

Statewide Survey of Drug and Alcohol Use among California Students in Grades 7, 9, and 11. Winter 1995-96. Sixth Biennial.

ERIC Educational Resources Information Center

Austin, Gregory; Skager, Rodney

The California Student Substance Use Survey marks a milestone in the state's efforts to monitor, understand, and prevent adolescent substance use and abuse. Chapter 1 presents the methodology. This survey follows a shift in California policy to a written parental consent requirement. Sample characteristics, consent procedures, and methods of data…

77 FR 69505 - Notice of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

... application forms, parental consent forms, and pre and post parent/student surveys. Surveys are designed to... programs are designed to engage underrepresented rising 5th-8th grade students in a one-on-one virtual... mentoring opportunities in science, technology, engineering, and math (STEM) disciplines for female students...

Universal HIV Screening at Postnatal Points of Care: Which Public Health Approach for Early Infant Diagnosis in Côte d'Ivoire?

PubMed Central

Ndondoki, Camille; Brou, Hermann; Timite-Konan, Marguerite; Oga, Maxime; Amani-Bosse, Clarisse; Menan, Hervé; Ekouévi, Didier; Leroy, Valériane

2013-01-01

Background Universal HIV pediatric screening offered at postnatal points of care (PPOC) is an entry point for early infant diagnosis (EID). We assessed the parents' acceptability of this approach in Abidjan, Côte d'Ivoire. Methods In this cross-sectional study, trained counselors offered systematic HIV screening to all children aged 6–26 weeks attending PPOC in three community health centers with existing access to HAART during 2008, as well as their parents/caregivers. HIV-testing acceptability was measured for parents and children; rapid HIV tests were used for parents. Both parents' consent was required according to the Ivorian Ethical Committee to perform a HIV test on HIV-exposed children. Free HIV care was offered to those who were diagnosed HIV-infected. Findings We provided 3,013 HIV tests for infants and their 2,986 mothers. While 1,731 mothers (58%) accepted the principle of EID, only 447 infants had formal parental consent 15%; 95% confidence interval (CI): [14%–16%]. Overall, 1,817 mothers (61%) accepted to test for HIV, of whom 81 were HIV-infected (4.5%; 95% CI: [3.5%–5.4%]). Among the 81 HIV-exposed children, 42 (52%) had provided parental consent and were tested: five were HIV-infected (11.9%; 95% CI: [2.1%–21.7%]). Only 46 fathers (2%) came to diagnose their child. Parental acceptance of EID was strongly correlated with prenatal self-reported HIV status: HIV-infected mothers were six times more likely to provide EID parental acceptance than mothers reporting unknown or negative prenatal HIV status (aOR: 5.9; 95% CI: [3.3–10.6], p = 0.0001). Conclusions Although the principle of EID was moderately accepted by mothers, fathers' acceptance rate remained very low. Routine HIV screening of all infants was inefficient for EID at a community level in Abidjan in 2008. Our results suggest the need of focusing on increasing the PMTCT coverage, involving fathers and tracing children issued from PMTCT programs in low HIV prevalence countries. PMID:23990870

The Hatch Amendment: A Primer for Counselors, Part II.

ERIC Educational Resources Information Center

Kaplan, Leslie S.; Geoffroy, Kevin

1987-01-01

Explores the legislative decisions concerning parental versus state control of education in light of the Hatch Amendment. Suggests ways for educators and counselors to deal with the amendment by recognizing limitations of the amendment, developing procedures for determining when written parental consent is required, and developing and publishing a…

29 CFR 519.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... school hours and in any occupation declared hazardous by the Secretary of Labor (subpart E-1 of part 570... in agriculture of a full-time student outside school hours for the school district where such... parental or guardian consent or they may work on farms where their parents or guardians are employed, and...

29 CFR 519.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... school hours and in any occupation declared hazardous by the Secretary of Labor (subpart E-1 of part 570... in agriculture of a full-time student outside school hours for the school district where such... parental or guardian consent or they may work on farms where their parents or guardians are employed, and...

29 CFR 519.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... school hours and in any occupation declared hazardous by the Secretary of Labor (subpart E-1 of part 570... in agriculture of a full-time student outside school hours for the school district where such... parental or guardian consent or they may work on farms where their parents or guardians are employed, and...

Communicating with parents about vaccination: a framework for health professionals.

PubMed

Leask, Julie; Kinnersley, Paul; Jackson, Cath; Cheater, Francine; Bedford, Helen; Rowles, Greg

2012-09-21

A critical factor shaping parental attitudes to vaccination is the parent's interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Literature review to identify a spectrum of parent attitudes or 'positions' on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Five distinct parental groups were identified: the 'unquestioning acceptor' (30-40%), the 'cautious acceptor' (25-35%); the 'hesitant' (20-30%); the 'late or selective vaccinator' (2-27%); and the 'refuser' of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents' readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent's own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Health professionals have a central role in maintaining public trust in vaccination, including addressing parents' concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to guide parents towards quality decisions.

Factors affecting consent in pediatric critical care research.

PubMed

Menon, Kusum; Ward, Roxanne E; Gaboury, Isabelle; Thomas, Margot; Joffe, Ari; Burns, Karen; Cook, Deborah

2012-01-01

Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors. A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters. We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88). This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.

Childhood immunization: when physicians and parents disagree.

PubMed

Gilmour, Joan; Harrison, Christine; Asadi, Leyla; Cohen, Michael H; Vohra, Sunita

2011-11-01

Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

The objective measurement of physical activity and sedentary behaviour in 2-3 year olds and their parents: a cross-sectional feasibility study in the bi-ethnic Born in Bradford cohort.

PubMed

Costa, Silvia; Barber, Sally E; Cameron, Noël; Clemes, Stacy A

2015-11-11

The reported lower physical activity (PA) levels of British South Asians (SA) are suggested as a key influence in their increased risk of non-communicable diseases compared to their White British peers. Differences in objectively measured PA and sedentary behaviour (SB) between these ethnic groups have been observed during childhood (ages: 8-10 years). However, no information exists on objectively measured PA/SB in younger children, or how early in life differences in these behaviours emerge. Assessing PA/SB in the Born in Bradford (BIB) cohort study provides an opportunity to address such gaps in the literature, but previous studies have found recruiting and retaining SA participants challenging, and the feasibility of using accelerometers with SA children and parents is unknown. This study investigated the feasibility of recruiting and objectively measuring the habitual PA/SB of 2-3 year old SA and White British children and parents from the BIB study. Families were informed about the study during routine BIB assessments. Consenting families were visited at home for anthropometry measurements, interviews, material delivery and collection. Participants (child and parents) were instructed to wear the ActiGraph GT3X+ for 8 days. Descriptive statistics were computed, and ethnic differences tested (Chi-square) for recruitment uptake and compliance. 160 families (30 % SA) provided contact details, and 97 (22 % SA) agreed to enter the study. White British families showed lower refusal and higher intake into the study than SA (p = 0.006). Of 89 children issued with an accelerometer, 34 % complied with the 8-day protocol (significantly less SA; p = 0.015) and 75 % provided enough days (≥ 3) to assess habitual PA/SB (no ethnic differences). Parental rates of compliance with the protocol did not differ between ethnicities. Issues experienced with the protocol and accelerometer use, and successful implementation strategies/procedures are presented. Although greater efforts may be required to recruit SA, those consenting to participate were as likely as White British to provide enough data to assess habitual PA/SB. The issues and successful strategies reported in this feasibility study represent valuable information for planning future studies, and enhance recruitment and compliance with accelerometer protocols in SA and White British toddlers and parents.

Parents, adolescents, and consent for research participation.

PubMed

Iltis, Ana S

2013-06-01

Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

PubMed

Cave, Emma; Wallbank, Julie

2012-01-01

Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinician's point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minor's understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

Sterilizing the mentally-handicapped: who can give consent?

PubMed

1980-01-26

Due to the vulnerable position of the mentally handicapped individual, the question of whether the state or any other interested 3rd party should intervene in procreative rights even with consent will depend to a great extent on the ability and autonomy of the individual to make the decision. There are 3 elements to consent: 1) it must be voluntary; 2) it requires that the individual has sufficient information to make a decision; and 3) it is imperative that the person providing the consent have the mental competence to appreciate exactly what is being consented to and the implication of the consent. Consent can be either personal consent or it may be "3rd party" consent. The 3rd party consent is used when an individual is incapable of providing personal consent. It is crucially important that those mentally handicapped individuals who are capable of making a decision do make such a decision when they agree to undergo sterilization. There is nothing inherent in mental handicap that prevents an individual from providing competent consent to a sterilization. The situation when someone other than the individual to be sterilized consents to the procedure poses more problems. Some glaring problems that arise when 3rd party consent on behalf of full-time residents in state institutions is allowed are the following: 1) state coercion behind such decisions is too easily concealed; 2) persuasion can be brought to bear on parents who already bear the stigma of a mentally handicapped child; and 3) administrative convenience may too easily be substituted for the benefit to the individual.

32 CFR Appendix F to Part 57 - Parent and Student Rights

Code of Federal Regulations, 2014 CFR

2014-07-01

... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

32 CFR Appendix F to Part 57 - Parent and Student Rights

Code of Federal Regulations, 2010 CFR

2010-07-01

... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

32 CFR Appendix F to Part 57 - Parent and Student Rights

Code of Federal Regulations, 2013 CFR

2013-07-01

... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

32 CFR Appendix F to Part 57 - Parent and Student Rights

Code of Federal Regulations, 2012 CFR

2012-07-01

... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

32 CFR Appendix F to Part 57 - Parent and Student Rights

Code of Federal Regulations, 2011 CFR

2011-07-01

... of a child with a disability or suspected of having a disability shall be obtained before any of the... educational placement. (iii) Change in EIS or educational placement. (2) If a parent of an infant or toddler... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial...

Student Data and Consent Policies: Avoiding Unintended Consequences. Safeguarding Data: Briefs for Policymakers

ERIC Educational Resources Information Center

Data Quality Campaign, 2014

2014-01-01

Schools use data for different purposes, which have different degrees of impact on a student's educational experience: administrative, instructional, assessment and measurement, and optional/noneducational. To the extent feasible, parental choice policies should be structured according to the use of the data in question. Parents should have more…

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

PubMed

Friedlander, Joel A; Loeben, Greg S; Finnegan, Patricia K; Puma, Anita E; Zhang, Xuemei; de Zoeten, Edwin F; Piccoli, David A; Mamula, Petar

2011-04-01

To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

Assent in research: the voices of adolescents

PubMed Central

Grady, Christine; Wiener, Lori; Abdoler, Emily; Trauernicht, Emily; Zadeh, Sima; Diekema, Douglas S.; Wilfond, Benjamin S.; Wendler, David

2014-01-01

Purpose Adolescents join clinical research after investigators obtain their positive agreement, or ‘assent.’ Although intended to respect adolescents, little is known about the views of adolescents or their parents regarding assent or research enrollment decisions. This study aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission. Methods Structured interviews were conducted with 13 through 17 year old teens, enrolled in clinical research at NIH or Seattle Children’s Hospital, and separately with one parent. Results 177 adolescent-parent pairs were interviewed. Teens were well distributed by age and gender, represented a wide variety of research and illnesses ranging in severity from mild to life-threatening; 20% were healthy volunteers. Teens and parents were generally satisfied with the assent/permission process. Normally, they made the enrollment decision together and teens wanted parents’ input and support. About 25% of teens reported pressure to enroll, from parents or relatives, but also from doctors/nurses/research teams. Only 2% of teens preferred not to sign a consent form. Conclusions Despite some differing views about how decisions should be made, the current assent/permission process is perceived as satisfactorily respectful by most teens in research. Many teens want to sign consent forms and teens’ signatures should generally be sought. Flexible guidance allows research teams and IRBs to customize the assent process for teens in particular studies in order to facilitate an appropriate balance between giving teens a voice reflective of their emerging independence and enabling supportive collaboration with parents. PMID:24630932

Parent influences on preschoolers' objectively assessed physical activity.

PubMed

Oliver, Melody; Schofield, Grant M; Schluter, Philip J

2010-07-01

The purposes of this study were to examine the relationship between accelerometer-derived physical activity (PA) in preschoolers and their parents, and to investigate other potential child and parental associates of child PA. Families of children aged 2-5 yrs were recruited in Auckland, New Zealand, from October 2006 to July 2007. Consenting children and parents had their height, weight, and waist circumference measured and were asked to wear accelerometers over 7 consecutive days, measuring PA in 15s epochs. Accelerometer data were gathered from 78 children, 62 mothers and 20 fathers over a median of 6.5-7 days, and converted to estimated daily PA rates for each individual using negative binomial generalised estimating equation (GEE) modelling. Potential associates of children's daily PA rates were then assessed using normal GEE models with exchangeable correlation structures. After taking account of all factors in the final multivariable model, parental PA rates (coefficient 0.09, 95% CI 0.03, 0.16, P=0.01) and child age (coefficient 0.11, 95% CI 0.01, 0.21, P=0.03) were the only factors significantly associated with child PA rates. Younger children may stand to benefit from PA intervention, and encouraging parental involvement in preschool PA interventions may be useful for increasing PA levels in young children. More work in this field is needed to corroborate these findings, improve generalisability, and determine causality. Copyright 2009 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

PubMed

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Parent's Guide to Special Education in Washington State, 1985-86 [and] Guia para Padres: Para Educacion Especial en el Estado de Washington.

ERIC Educational Resources Information Center

Washington Office of the State Superintendent of Public Instruction, Olympia.

This pamphlet guides parents of children with disabilities through the procedures for acquiring special education services in the state of Washington. Following an overview of special education, the pamphlet presents information on notice and consent procedures, confidentiality of records, individualized education programs (IEP), the placement…

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing

PubMed Central

Sénécal, Karine; Thys, Kristof; Vears, Danya F; Van Assche, Kristof; Knoppers, Bartha M; Borry, Pascal

2016-01-01

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as ‘young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of ‘minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle. PMID:27302841

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing.

PubMed

Sénécal, Karine; Thys, Kristof; Vears, Danya F; Van Assche, Kristof; Knoppers, Bartha M; Borry, Pascal

2016-11-01

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as 'young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of 'minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle.

Conflict resolution in the parent-child, marital, and peer contexts and children's aggression in the peer group: a process-oriented cultural perspective.

PubMed

Feldman, Ruth; Masalha, Shafiq; Derdikman-Eiron, Ruth

2010-03-01

Theories of socialization propose that children's ability to handle conflicts is learned at home through mechanisms of participation and observation-participating in parent-child conflict and observing the conflicts between parents. We assessed modes of conflict resolution in the parent-child, marriage, and peer-group contexts among 141 Israeli and Palestinian families and their 1st-born toddler. We observed the ecology of parent-child conflict during home visits, the couple's discussion of marital conflicts, and children's conflicts with peers as well as aggressive behavior at child care. Israeli families used more open-ended tactics, including negotiation and disregard, and conflict was often resolved by compromise, whereas Palestinian families tended to consent or object. During marital discussions, Israeli couples showed more emotional empathy, whereas Palestinians displayed more instrumental solutions. Modes of conflict resolution across contexts were interrelated in culture-specific ways. Child aggression was predicted by higher marital hostility, more coparental undermining behavior, and ineffective discipline in both cultures. Greater family compromise and marital empathy predicted lower aggression among Israeli toddlers, whereas more resolution by consent predicted lower aggression among Palestinians. Considering the cultural basis of conflict resolution within close relationships may expand understanding on the roots of aggression.

Communicating with parents about vaccination: a framework for health professionals

PubMed Central

2012-01-01

Background A critical factor shaping parental attitudes to vaccination is the parent’s interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Methods Literature review to identify a spectrum of parent attitudes or ‘positions’ on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Results Five distinct parental groups were identified: the ‘unquestioning acceptor’ (30–40%), the ‘cautious acceptor’ (25–35%); the ‘hesitant’ (20–30%); the ‘late or selective vaccinator’ (2–27%); and the ‘refuser’ of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents’ readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent’s own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Conclusions Health professionals have a central role in maintaining public trust in vaccination, including addressing parents’ concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to guide parents towards quality decisions. PMID:22998654

The Influence of Partner Status and Sexual Behavior on College Women's Consent Communication and Feelings.

PubMed

Marcantonio, Tiffany; Jozkowski, Kristen N; Wiersma-Mosley, Jackie

2018-05-09

Sexual consent has permeated mainstream discourse as a mechanism used to decrease rates of sexual assault and increase sex-positive communication. Women's external consent behaviors are frequently examined; however, research exploring their internal consent and feelings associated with sexual activity are understudied. The purpose of this study was to understand how partner status and sexual behavior at most recent sexual activity influence women's external/internal consent and feelings during sexual activity. Three-hundred and ninety women completed a survey on consent, partner status, and most recent sexual behavior. Internal and external consent differed by partner status for women who engaged in vaginal-penile sex, but not genital and oral sex. Feelings associated with the sexual act were different within each behavior group and partner status. Women with a serious dating partner reported stronger feelings related to sexual activity, higher internal consent feelings, and increased use of non-verbal external consent cues. Partner status appears to influence factors of interest for vaginal-penile sex, but not genital and oral sex. Findings from this study can inform prevention efforts to increase sex-positive communication around consent.

Autism beyond pediatrics: why bioethicists ought to rethink consent in light of chronicity and genetic identity.

PubMed

Perry, Alexandra

2012-06-01

Autism is a chronic neurodevelopmental disorder that presents unique challenges to bioethicists. In particular, bioethicists ought to reconsider pediatric consent in light of disparity between beliefs that are held about the disorder by parents and adults with autism. The neurodiverse community ought to be given some consideration in this debate, and, as such, there may be a role for autistic narratives in clarifying this problem. © 2011 Blackwell Publishing Ltd.

Parental Consent Act of 2009

THOMAS, 111th Congress

Rep. Paul, Ron [R-TX-14

2009-04-30

House - 06/04/2009 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Parental Consent Act of 2011

THOMAS, 112th Congress

Rep. Paul, Ron [R-TX-14

2011-08-01

House - 09/08/2011 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

[The awareness of pediatricians about ethical legal issues of medical care provision].

PubMed

Polunina, N V; Shmelev, I A; Konovalov, O A

2016-01-01

The implementation of rights of under-age patients in medical institutions in many ways depends on level of awareness of pediatricians about availability and mechanisms of legal guarantees provided to them by law and hence depends quality of medical care of children population. The study was carried out to analyze opinions of pediatricians about issues of implementation of rights of patients. The results are presented concerning sociological survey of 261 pediatricians of the Samarskaia oblast. The study established inadequate awareness of respondents about ethical legal issues of medicine and rate of application of knowledge about legal acts in practical activity. The awareness was higher among pediatricians of younger age with duration of professional work lesser than 10 years. This phenomenon is explained by inclusion of courses of biomedical ethics and medical law in educational programs of medical educational institutions during last decade. The direct dependence is established between awareness of pediatricians about issues of bioethics and the level of their qualification. The most of the respondents consider that the have sufficient level of knowledge about rights of children-patients and their parents related to reservation of medical secrecy, consent or refuse of parents to medical intervention and receiving full information about child's health. The overwhelming majority of pediatricians, independently of professional category and duration of service, provided this right implementing modern informational and collegiate model of interaction with parents of ill child and informed that always obtained their consent about medical care. However, such rights of children were limited by framework of child's health and ability for apprehending information about one's health and prospective medical intervention. All respondents participated in survey insisted that they never disclosed medical secrecy. The development of legal literacy of pediatricians by promoting activities of organizational methodical departments of medical organizations and self-contained studying of normative legal acts.

Motivating Cord Blood Donation with Information and Behavioral Nudges.

PubMed

Grieco, Daniela; Lacetera, Nicola; Macis, Mario; Di Martino, Daniela

2018-01-10

Umbilical cord blood is a source of hematopoietic stem cells essential to treat life-threatening diseases, such as leukemia and lymphoma. However, only a very small percentage of parents donate upon delivery. The decision to donate the cord blood occurs at a very specific time and when parents likely experience emotional, informational, and decisional overloads; these features of cord blood donation make it different from other pro-social activities. In collaboration with an OB-GYN clinic in Milan, Italy, we conducted the first randomized controlled trial that applies tools from behavioral science to foster cord blood donation, and quantified the gains that informational and behavioral "nudges" can achieve. We found that information and "soft" commitments increased donations; approaching expecting parents closer to the delivery date and providing them with multiple reminders, moreover, had the strongest impact. However, a significant portion of women who expressed consent to donate could not do so because of organizational constraints. We conclude that simple, non-invasive behavioral interventions that address information gaps and procrastination, and that increase the salience of the activity can substantially enhance altruistic donations of cord blood, especially when coupled with organizational support.

Immunity from criminal prosecution for parents who withhold medically necessary treatment from children on religious grounds.

PubMed

Dickinson, M L; Weinstein, K R

1995-05-01

Because child endangerment laws and their judicial interpretation are different in each state, healthcare providers should familiarize themselves with the law in their particular jurisdiction. In situations in which parents refuse on religious grounds to consent to medical treatment for their children, health care providers should consult local counsel as to the legal options available.

[Teenage pregnancies, legal aspects].

PubMed

Rogue, Fanny

2016-01-01

Minor girls are legally considered as incapable, under the authority of their parents. Difficulties can arise when a minor becomes pregnant. The law takes account of this situation: under certain conditions, she can decide by herself to undertake certain actions, medical or otherwise, without the consent of her parents. These include access to contraception, abortion or anonymous birth. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

To Consent or Decline HPV Vaccination: A Pilot Study at the Start of the National School-Based Vaccination Program in Sweden

ERIC Educational Resources Information Center

Grandahl, Maria; Tydén, Tanja; Westerling, Ragnar; Nevéus, Tryggve; Rosenblad, Andreas; Hedin, Erik; Oscarsson, Marie

2017-01-01

Background: Parents' beliefs about human papillomavirus (HPV) vaccination influence whether they allow their daughters to be vaccinated. We examined the association between parents' refusal and sociodemographic background, knowledge and beliefs about HPV, and the HPV vaccination in relation to the Health Belief Model. Methods: The sample consisted…

Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

PubMed Central

2010-01-01

Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It!) program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a national program. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12610000200088 PMID:20426840

Children's Privacy Protection and Parental Empowerment Act of 1996. Hearing on H.R. 3508 before the Subcommittee on Crime of the Committee on the Judiciary. House of Representatives, One Hundred Fourth Congress, Second Session. (September 12, 1996).

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on the Judiciary.

This hearing examined issues related to H.R. 3508, the Children's Privacy Protection and Parental Empowerment Act of 1996, which prohibits the sale of personal information about children without parents' written consent, and the use of prisoner labor to process personal information about children. The Act also establishes a criminal penalty for…

An audit of parents'/guardians' wishes recorded after coronial autopsies in cases of sudden unexpected death in infancy: issues raised and future directions.

PubMed

Cohen, M C; Blakey, S; Donn, T; McGovern, S; Parry, L

2009-07-01

In the U.K., cases of sudden unexpected death in infancy are under the jurisdiction of the Coroner and consent for a post-mortem is not required. Prior to the Human Tissue Act 2006 (HTA) there was also no requirement to request retention of tissue (blocks and slides). The HTA stipulates that parental/ guardian consent is mandatory to retain or dispose of all tissues after the Coroners' purposes have been fulfilled. In 2007, in order to avoid confusion with the consent needed for hospital post-mortems, a new form was introduced by Sheffield Children's Hospital NHS Foundation Trust (SCH) called Record of parents'/guardians'wishes regarding samples taken at a Coroner's post mortem. This version specifically asks if blocks and slides may be retained as part of the medical record, or are to be disposed of, and for parental agreement (or not) for the frozen tissue, blocks and slides to be used for education, audit, quality control and medical research. One hundred and nineteen Coroners' postmortems covering the years 2006-2007 were reviewed. All parents/guardians (P/G) were contacted and the outcomes of P/G wishes recorded by SCH staff, Coroners' Officers (CO) and Police Family Liaison Officers (PFLO) were analysed and compared (44% from CO were outstanding at the time of audit). Any delay in recording P/G wishes by these three groups was also compared. In 2006, parental agreement to the use of blocks and slides for education, audit, quality control and medical research was 94%, 77% and 75% for SCH, CO and PFLO, respectively. In 2007 it was 84%, 37% and 100% for the same groups. Permission for the retention of frozen tissue given to SCH, CO and PFLO was 90%, 62% and 100% in 2006 and 90%, 44% and 100% in 2007, respectively. Cases where parents did not wish for the retention or use of tissue (including blocks and slides) were 3%, 15% and 0% in 2006 for SCH, CO and PFLO respectively, and 0% for all groups in 2007. Training of staff in all aspects of post-mortem and bereavement care is essential for ascertaining parental wishes. Families should be provided with the knowledge that allows them to make informed choices. The analysis of the results of the audit supports this view.

Defining the Pathways of Parental Decision-making and Satisfaction Levels About Newborn Circumcision in a Setting Where Traditional Male Circumcision is Prevalent: An Online Survey Study.

PubMed

Özveren, Bora

2016-04-01

To investigate the decision-making attitudes, course of informed consent, and satisfaction levels of parents who opted for newborn circumcision (NC) in a societal setting where the timing of circumcision is generally determined by tradition. Online questionnaire was sent to 1235 parents of boys who had NC. The response rate was 50.4%. The final decision of newborn circumcision depended on the mother in 51.47%. Nearly 75% of circumcisions were performed before hospital discharge. The most common (70.65%) reported reason for parents' choice was medical/hygienic. When evaluating their decision, 93.05% refused any feelings of regret and 96.26% stated they would decide the same if they had another son. The source of information on newborn circumcision was mostly physicians (39.27%), followed by friends and family (31.2%). Parental preference, having nonreligious motives, and being previously informed about the procedure by experienced peers appeared as significant factors on the decision regarding timing of NC. In total, 79.90% ranked their satisfaction level as "very satisfied" on a Likert scale. The mean rate of satisfaction was significantly higher in parents who acquired previous information from healthcare providers and who acknowledged sufficient preprocedural counseling before giving consent. In a society where the timing of circumcision is usually determined by faiths and traditions, parental decision-making on newborn circumcision is greatly influenced by personal choices of parents, based on timely, accurate, and adequate information received from peers and healthcare providers. Medical providers play an important role on the informed decision of parents and impact on satisfaction with prior decision and outcomes of newborn circumcision. Copyright © 2016 Elsevier Inc. All rights reserved.

Parental Consent Act of 2011

THOMAS, 112th Congress

Sen. Paul, Rand [R-KY

2011-11-03

Senate - 11/03/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Values Clarification: Your Job or Mine?

ERIC Educational Resources Information Center

McGough, Kris

1977-01-01

The author criticizes values clarification techniques done without parental consent in non-elective courses because they invade privacy, lead to ethical relativism, and have the potential to damage children's ego-strength. (Author/AV)

12 CFR 980.6 - Finance Board consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

42 CFR 483.410 - Condition of participation: Governing body and management.

Code of Federal Regulations, 2013 CFR

2013-10-01

... treatment, social information, and protection of the client's rights. (2) The facility must keep... client information, including consents necessary from the client, or parents (if the client is a minor...

42 CFR 483.410 - Condition of participation: Governing body and management.

Code of Federal Regulations, 2014 CFR

2014-10-01

... treatment, social information, and protection of the client's rights. (2) The facility must keep... client information, including consents necessary from the client, or parents (if the client is a minor...

42 CFR 483.410 - Condition of participation: Governing body and management.

Code of Federal Regulations, 2012 CFR

2012-10-01

... treatment, social information, and protection of the client's rights. (2) The facility must keep... client information, including consents necessary from the client, or parents (if the client is a minor...

Research ethics committee decision-making in relation to an efficient neonatal trial.

PubMed

Gale, C; Hyde, M J; Modi, N

2017-07-01

Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

American Academy of Pediatrics v. Lungren.

PubMed

1996-04-04

The California Supreme Court held that a state statute that requires unemancipated minors to obtain parental consent to abortion or to petition the juvenile court for permission to consent to that procedure (1) does not violate an unemancipated minor's right to privacy under the state constitution; (2) does not violate minors' rights to informational privacy; and (3) does not violate equal protection. The court reasoned that the privacy interests of an unemancipated minor are "qualitatively different" from those of an adult and therefore subject both to reasonable regulation by the state to an extent not permissible with adults and to control by the unemancipated minor's parents to an even greater extent. The court also determined that the required disclosure of medical information was minimal and necessary and that the statute does not discriminate on the basis of the unemancipated minor's reproductive choice.

Interpretation of Do Not Attempt Resuscitation Orders for Children Requiring Anesthesia and Surgery.

PubMed

Fallat, Mary E; Hardy, Courtney

2018-05-01

This clinical report addresses the topic of pre-existing do not attempt resuscitation or limited resuscitation orders for children and adolescents undergoing anesthesia and surgery. Pertinent considerations for the clinician include the rights of children, decision-making by parents or legally approved representatives, the process of informed consent, and the roles of surgeon and anesthesiologist. A process of re-evaluation of the do not attempt resuscitation orders, called "required reconsideration," should be incorporated into the process of informed consent for surgery and anesthesia, distinguishing between goal-directed and procedure-directed approaches. The child's individual needs are best served by allowing the parent or legally approved representative and involved clinicians to consider whether full resuscitation, limitations based on procedures, or limitations based on goals is most appropriate. Copyright © 2018 by the American Academy of Pediatrics.

WHEN PARENTS CHOOSE GENDER: INTERSEX, CHILDREN, AND THE LAW.

PubMed

Newbould, Melanie

2017-01-05

In England and Wales, it is usually lawful for those with parental responsibility to consent to treatment on children who have not acquired legal capacity, providing that they are acting in the child's best interests. Whilst in most instances this process is unproblematic and the decisions made are non-controversial, there are troubling examples where this is more problematic. The difficulties for a family with a child who has an intersex condition will be considered to illustrate that there may be cases of medical and surgical treatment where even though both parents and doctors agree on a course of action in good faith, the treatment administered may not necessarily be in the best interests of the child. Sometimes, procedures carried out on an infant apparently in their best interests may later be a cause of regret to the child as an adult. The law in England and Wales will be examined to investigate other examples of controversial treatments of young children involving legal interventions to consider whether there are any parallels and what the implications of these might be to the intersex child. A model suggested by a Columbian legal case from 1995 is discussed. The courts ruled that infantile sex assignment surgery is lawful only following very stringent consent procedures. The possibility is considered that guidelines defining the consent procedure may afford some protection for the intersex child. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

When neonatal ICU infants participate in research: special protections for special subjects.

PubMed

Thomas, Karen A

2009-06-01

Neonatal ICU research poses unique concerns for infants and parents. Children are considered a vulnerable research population. Federal regulations specify special protections when children participate in research. These regulations determine the types of research approvable for children based on the balance of risks and benefit. Risk also determines whether one or both parents' consent is required for their infant's participation in research.

[Informed consent and parental refusal to medical treatment in childhood. The threshold of medical and social tolerance. Part I].

PubMed

Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

Informed consent is a right of all individuals and no one can force anyone to receive treatment against their wishes. The right to accept or refuse treatment persists in individuals who are incompetent from a legal point of view; this is exercised on their behalf by a third party. Children are considered incompetent to make medical decisions about their own health and their parents or legal guardians are empowered to make those decisions. However, parental authority is not absolute and there are situations where their decisions are not the best, sometimes leading to jeopardizing the well-being and even the lives of their children, forcing the state to intervene on behalf of the best interests of the child. This is the reason why it is necessary to ask the following questions: is it really the child's best interest that moves us to legally intervene when a parent refuses to accept the proposed medical treatment or is the damage done to make this decision? What kind of parental decisions are those that should not be tolerated? After a review of the theme, we conclude that if the decision of the parents regarding a medical decision is considered to be made with maleficence that is harmful to the child, it is justified that the State intervenes. Finally, we exposed four criteria that can be used in making decisions in complex cases where parents refuse treatment for their children. Copyright © 2015. Publicado por Masson Doyma México S.A.

Correlates of weight status among Norwegian 11-year-olds: The HEIA study.

PubMed

Grydeland, May; Bergh, Ingunn H; Bjelland, Mona; Lien, Nanna; Andersen, Lene F; Ommundsen, Yngvar; Klepp, Knut-Inge; Anderssen, Sigmund A

2012-12-06

The underlying mechanisms of overweight and obesity in adolescents are still not fully understood. The aim of this study was to investigate modifiable and non-modifiable correlates of weight status among 1103 Norwegian 11-year-old adolescents in the HEalth in Adolescents (HEIA) study, including demographic factors such as gender and parental education, and behavioral factors such as intake of sugar-sweetened beverages, snacks and breakfast consumption, watching TV and playing computer games, physical activity and sedentary time. Weight and height were measured objectively, body mass index (BMI) was calculated and International Obesity Task Force cut-offs were used to define weight status. Physical activity and sedentary time were measured by accelerometers. Other behavioral correlates and pubertal status were self-reported by questionnaires. Parental education was reported by the parents on the consent form for their child. Associations were investigated using logistic regressions. There were gender differences in behavioral correlates of weight status but not for weight status itself. Adolescents with parents in the highest education category had a 46% reduced odds of being overweight compared to adolescents with parents in the lowest education category. Adolescents with parents with medium education had 42% lower odds of being overweight than adolescents with parents with the lowest education category. Level of parental education, breakfast consumption and moderate to vigorous physical activity were positively associated with being normal weight, and time watching TV was positively associated with being overweight for the total sample. Gender differences were detected; boys had a doubled risk of being overweight for every additional hour of watching TV per week, while for girls there was no association. The present study showed a social gradient in weight status in 11-year-olds. Both breakfast consumption and moderate to vigorous physical activity were inversely associated with weight status. No associations were found between intake of sugar-sweetened beverages and snacks, playing computer games and weight status. Watching TV was positively associated with weight status for boys but not for girls. Interventions are needed to gain more insight into the correlates of change in weight status.

Influence of parental alcohol-related attitudes, behavior and parenting styles on alcohol use in late and very late adolescence.

PubMed

Stafström, Martin

2014-01-01

Parents influence adolescent drinking behavior, but to what extent does this association diminish with age, however? The cross-sectional data was drawn from the Scania drug use survey 2007, consisting of 4,828 secondary education students in the 9th and 11th grade. The age- and gender-adjusted findings indicate that having parents who are consenting to alcohol use (OR 1.4), having been provided with alcohol by one's parents (OR 1.8), having parents with an authoritarian (OR 1.5) or neglectful (OR 2.1) parenting style, and having parents who both have a university degree (OR 1.3) were factors significantly associated with monthly heavy episodic drinking. These findings lead to the conclusion that parenting styles as well as parental attitudes and behaviors are important throughout the high school years. Thus, prevention targeting parents should emphasize both these domains. © 2014 S. Karger AG, Basel.

An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

PubMed

Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

2017-02-01

The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

38 CFR 14.705 - Authority to file petitions for appointment of fiduciaries in State courts.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the written consent of: (1) The beneficiary's spouse. (2) The beneficiary's adult child, parent, adult... expenses, including witness fees, appeal bonds, advertising in any newspaper or other publication...

How do parents experience being asked to enter a child in a randomised controlled trial?

PubMed

Shilling, Valerie; Young, Bridget

2009-02-16

As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.

The limits of parental responsibility regarding medical treatment decisions.

PubMed

Woolley, Sarah L

2011-11-01

Parental responsibility (PR) was a concept introduced by the Children Act (CA) 1989 which aimed to replace the outdated notion of parental rights and duties which regarded children as parental possessions. Section 3(1) CA 1989 defines PR as 'all the rights, duties, powers, responsibilities and authority which by law a parent of a child has in relation to the child'. In exercising PR, individuals may make medical treatment decisions on children's behalf. Medical decision-making is one area of law where both children and the state can intercede and limit parental decision-making. Competent children can consent to treatment and the state can interfere if parental decisions are not seemingly in the child's 'best interests'. This article examines the concept, and limitations, of PR in relation to medical treatment decision-making.

12 CFR 980.6 - Finance Board consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to...

Optimization of informed consent for umbilical cord blood banking.

PubMed

Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

2002-12-01

The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

Parental Grief Following the Brain Death of a Child: Does Consent or Refusal to Organ Donation Affect Their Grief?

ERIC Educational Resources Information Center

Bellali, Thalia; Papadatou, Danai

2006-01-01

The purpose of this study was to investigate the grieving process of parents who were faced with the dilemma of donating organs and tissues of their underage brain dead child, and to explore the impact of their decision on their grief process. A grounded theory methodology was adopted and a semi-structured interview was conducted with 11 bereaved…

How modifiable factors influence parental decision-making about organ donation.

PubMed

Luberda, Kamila; Cleaver, Karen

2017-11-07

A global shortage of organs from children and adults available for transplantation is compounded by the failure of next of kin to consent for organs to be donated after death. Non-modifiable and modifiable factors influence decision-making in this area. Modifiable factors are of interest when examining families' decision-making about the donation of organs from their deceased child. A scoping review was undertaken to determine how modifiable factors influence parental decision-making about organ donation. Thematic analysis identified two themes: interactions with healthcare professionals and pre-disposition to organ donation. Satisfaction with experiences of hospital care, the information provided and the way it was communicated, as well as interactions pertaining to emotional support were all found to be modifiable factors that influenced decision making. Likewise, a predisposition to organ donation and knowing the deceased's wishes were associated with the consent decision. Nurses working in critical care environments need to be able to support parents during this difficult time. This article aims to raise awareness of modifiable factors that influence parental decision-making, highlighting their relevance for children's nursing practice. ©2017 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial.

PubMed

Rowe, Sarah L; Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-30

Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG). ©Sarah L Rowe, Krisna Patel, Rebecca S French, Claire Henderson, Dennis Ougrin, Mike Slade, Paul Moran. Originally published in JMIR Mental Health (http://mental.jmir.org), 30.01.2018.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial

PubMed Central

Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-01

Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. Trial Registration International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG) PMID:29382626

42 CFR 483.410 - Condition of participation: Governing body and management.

Code of Federal Regulations, 2011 CFR

2011-10-01

... information, and protection of the client's rights. (2) The facility must keep confidential all information..., including consents necessary from the client, or parents (if the client is a minor) or legal guardian. (4...

Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

PubMed

Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

2011-08-01

In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

Jehovah's Witness and consent for blood transfusion in a child: The Indian scenario.

PubMed

Gopakumar, K G; Priyakumari, T; Nair, Manjusha; Kusumakumary, P

2018-01-01

In India, the clinical guidelines and laws governing consent for blood transfusion in a minor are meager and vague. In an elective situation, whether the parents can make a decision for the child on his/her behalf or whether the doctor has the right to make the decision in the best interests of the child is not clear. We present the case scenario of a child belonging to Jehovah's Witness denomination diagnosed with Burkitt lymphoma. His parents were in a dilemma whether to opt for blood transfusion or not. In the absence of laws and guidelines in this context, and considering the complications that he developed during the treatment period, it was very challenging for us to manage the situation both medically and medico-legally. This situation highlights the need for framing consensus guidelines/laws regarding elective blood transfusion in a minor to make health-care delivery, smooth, transparent and flawless.

Communicating with parents of premature infants: who is the informant?

PubMed

Kowalski, W J; Leef, K H; Mackley, A; Spear, M L; Paul, D A

2006-01-01

To determine what sources of information are most helpful for neonatal intensive care unit (NICU) parents, who provides NICU parents with the information, and also what expectations parents have regarding obtaining information. A 19-item questionnaire was given to the parents of infants 32 weeks or younger prior to discharge from the NICU. Out of the 101 parents who consented, almost all of the parents (96%) felt that 'the medical team gave them the information they needed about their baby' and that the 'neonatologist did a good job of communicating' with them (91%). However, the nurse was chosen as 'the person who spent the most time explaining the baby's condition, 'the best source of information,' and the person who told them 'about important changes in their baby's condition' (P<0.01). Although the neonatologist's role in parent education is satisfactory, the parents identified the nurses as the primary source of information.

Child research in South Africa: How do the new regulations help?

PubMed

Strode, Ann Elaine; Slack, Catherine May

2015-11-01

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances.

Legal Barriers to Adolescent Participation in Research About HIV and Other Sexually Transmitted Infections

PubMed Central

Moore, Quianta L.; Paul, Mary E.; McGuire, Amy L.

2016-01-01

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as preexposure prophylaxis, without parental permission hinges on state minor consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. Unclear state laws may lead to research cessation. We have summarized legal, ethical, and policy considerations related to adolescents’ participation in HIV and sexually transmitted infection prevention research in the United States, and we have explored strategies for facilitating adolescents’ access. PMID:26562103

Child research in South Africa: How do the new regulations help?

PubMed Central

Strode, AE; Slack, CM

2018-01-01

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances. PMID:26632311

Perinatal postmortems: what is important to parents and how do they decide?

PubMed

Breeze, Andrew C G; Statham, Helen; Hackett, Gerald A; Jessop, Flora A; Lees, Christoph C

2012-03-01

Falling consent rates for postmortems, regardless of age of death, have been widely reported in recent years. The aim of this study was to explore parental attitudes to, and decision-making about, a perinatal postmortem after termination for fetal abnormality, late miscarriage, or stillbirth. A prospective self-completion questionnaire was given to 35 women and their partners. The participants had experienced second or third trimester pregnancy loss in a single fetal medicine and delivery unit in the United Kingdom and were making decisions about having a postmortem. They were asked to complete a questionnaire about their attitudes to, and expectations of, a perinatal postmortem. Thirty-one questionnaires were received from parents of 17 babies (49% of those asked; 16 from mothers, 15 from fathers). Parents of nine babies (53%) said they would agree to a full postmortem, of three babies to a limited postmortem, and of four babies to an external examination only; one couple were undecided. The most important issues for the parents in this study that related to their decisions about a postmortem centered on the need for information, both for future planning and about what had happened. Moderately important issues related to altruism, which is, improving medical knowledge and helping other parents experiencing similar bereavement. Among the lowest scoring issues were potential barriers, such as concerns about cultural or religious acceptability of a postmortem, funeral delays, and what would happen to the baby's body. Bereaved parents who participated in this study, where postmortem consent rates were relatively high, thought that their need for knowledge eclipsed assumed barriers when deciding whether or not to have a postmortem for their baby. © 2012, Copyright the Authors. Journal compilation © 2012, Wiley Periodicals, Inc.

Testicular tissue cryopreservation in prepubertal male children: an analysis of parental decision-making.

PubMed

Ginsberg, Jill P; Li, Yimei; Carlson, Claire A; Gracia, Clarisa R; Hobbie, Wendy L; Miller, Victoria A; Mulhall, John; Shnorhavorian, Margarett; Brinster, Ralph L; Kolon, Thomas F

2014-09-01

Infertility is an unfortunate treatment-related consequence for some pediatric malignancies as well as some non-malignant conditions treated with stem cell transplant. Unlike pubertal males, prepubertal males cannot produce semen for cryopreservation. This manuscript reports on the acceptability and safety of a multi-institutional protocol for offering testicular tissue cryopreservation to families of prepubertal male children at highest risk for infertility. Data on decision influences, decision-making control, and emotional state when considering this option are described. Prepubertal males facing gonadotoxic therapy were offered testicular cryopreservation. Post-biopsy, patients were followed for acute side effects. In addition, parents and patients were asked to complete questionnaires, whether or not they chose to cryopreserve tissue. Seventy-four prepubertal male children were approached. Fifty-seven families (77%) consented to the testicular biopsy; 48 of 57 underwent the procedure. There was one post-operative side effect. Parents who agreed to testicular cryopreservation and those that did not felt in control of this decision. Parents who consented to the biopsy and refusers were not deterred by the experimental nature of the protocol. An important decision-making influence was the risk of the biopsy. Biopsy and cryopreservation of testicular tissue from prepubertal male children was performed successfully and safely at three institutions. Parents faced with this option at diagnosis can make an informed decision and weigh carefully the risks and benefits. Although asked to make a decision soon after they were given a difficult diagnosis, parents uniformly felt in control of this decision. © 2014 Wiley Periodicals, Inc.

32 CFR 584.4 - Adoption proceedings.

Code of Federal Regulations, 2010 CFR

2010-07-01

... National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL FAMILY SUPPORT, CHILD... normally may not be put up for adoption without the consent of the parents. Therefore, communications from... with a copy of the communication and the reply. ...

Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

PubMed Central

Keel, Isabelle; Immer, Franz F.; Jüni, Peter

2014-01-01

Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. Results Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87). Conclusion Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

PubMed

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-03-21

Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings from this study question the validity of 'informed consent' as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process.

Consents or waivers of responsibility? Parents' information in NICU.

PubMed

Bellieni, Carlo V; Coradeschi, Caterina; Curcio, Maria R; Grande, Elisa; Buonocore, Giuseppe

2018-05-14

Informing the patient is a base of modern medicine; nonetheless, a great discrepancy exists between hospitals on the way this information should be administered. This is particularly important when the patient are babies: the information should be given to their parents who should approve or disapprove the treatment. Aim of this study is to assess the adequacy of the information administered to the parents of babies admitted into the Neonatal Intensive Care Units. We analyzed the consent forms of center-north Italy NICUs. To this aim, we assessed if the forms had acceptable length and other features; we then asked some volunteers to simulate an information process and to score the forms for their easiness, comprehensibility and explicability to others. Twenty-one NICUs accepted to participate. Only 7 out of 21 had an adequate information form; the other 14 could be described as "waiver of responsibility " (WOR), because they were too prolix and contained too many hypothetical procedures. The overall level of easiness, comprehensibility and explicability to others was suboptimal, being lower in those forms we defined WOR. The results are far to be optimal. More care should be devoted to the process of informing parents at the admission into the NICU: an information overload should be avoided and information should be tailored on the baby's state. Further analysis should be devoted to whether the use of WOR is routine in other countries.

Child consent and the law: an insight and discussion into the law relating to consent and competence.

PubMed

Parekh, S A

2007-01-01

The law governing consent for children is not very clear. A child can consent to treatment but usually in practice is unable to refuse it. Even if both the child and parents refuse treatment, courts are reluctant to accept this, particularly if it is in the best interest of the child. In order to consent to treatment, a child must be competent enough to do so, and this competence is judged usually by a doctor. Children can even consent to contraceptives and abortion if 'competent' to do so. This concept perfectly lacks moral, ethical and emotional competence, and judgement of competence is carried out usually purely scientifically by pure science-orientated objective professionals like doctors. A broad discussion about the issues of children refusing treatment is conducted from the legal, ethical and philosophical point of view. Life-saving treatment and various other cases are also discussed. There is no right answer to the question. A more holistic approach is needed, and not only doctors but also sociologists, care specialists and even clergymen should be asked to judge competence in a multidisciplinary environment, particularly for contraceptives and abortion. This multidisciplinary working can be extended to other areas in medical law as well particularly in light of changes in medicine. Experience in life should be valued in a decision-making environment for judging competence. The law in relation to child consent is unclear and requires changes in order to clarify what is perceived as the child's best interest.

Communication about the Risks and Benefits of Phase I Pediatric Oncology Trials

PubMed Central

Hazen, Rebecca A.; Zyzanski, Stephen; Baker, Justin; Drotar, Dennis; Kodish, Eric

2015-01-01

Introduction Phase 1 pediatric oncology trials offer only a small chance of direct benefit and may have significant risks and an impact on quality of life. To date, research has not examined discussions of risks and benefits during informed consent conferences for phase 1 pediatric oncology trials. The objective of the current study was to examine clinician and family communication about risks, benefits, and quality of life during informed consent conferences for phase 1 pediatric oncology trials. Methods Participants included clinician investigators, parents, and children recruited from 6 sites conducting phase 1 pediatric oncology trials. Eighty-five informed consent conferences were observed and audiotaped. Trained coders assessed discussions of risks, benefits, and quality of life. Types of risks discussed were coded (e.g., unanticipated risks, digestive system risks, death). Types of benefits were categorized as therapeutic (e.g. discussion of how participation may or may not directly benefit child), psychological, bridge to future trial, and altruism. Results Risks and benefits were discussed in 95% and 88% of informed consent conferences, respectively. Therapeutic benefit was the most frequently discussed benefit. The impact of trial participation on quality of life was discussed in the majority (88%) of informed consent conferences. Conclusion Therapeutic benefit, risks, and quality of life were frequently discussed. The range of information discussed during informed consent conferences suggests the need for considering a staged process of informed consent for phase 1 pediatric oncology trials. PMID:25638751

Effects of financial incentives on the intention to consent to organ donation: a questionnaire survey.

PubMed

Mayrhofer-Reinhartshuber, D; Fitzgerald, A; Benetka, G; Fitzgerald, R

2006-11-01

Shortage of donor organs is a serious problem for transplantation medicine. One controversial suggestion to increase the number of organ donors is financial incentives for consent. The aim of this study was to test whether different forms and amounts of financial incentives were apt to increase the consent to organ donation. Data were collected via questionnaires in urban and rural regions of Austria and randomly assigned to settings with three different amounts of financial incentives. The questionnaire was designed by using the theory of planned behaviour of Ajzen. Parents 69 mothers and 35 fathers; ages 25 to 65 years were evaluated for intention to consent to organ donation, perceived social norm, and positive/ negative aspects of organ donation without and with various financial incentives. The intention to consent to organ donation dropped highly significantly (Z = -7.556 P = .000) from the basic condition (M = 1.13; confidence interval [CIs] 0.78 to 1.51) to the condition with financial incentives (M = -1.58; CI, 1.96 to -1.15). No influence of the amount of financial incentive was observed. Highly significant differences were measured between both conditions for the social norm (Z = -5.638; P < .000) and the attitude toward organ donation (Z = -1.962; P < .05; Z = -2.104; P < .035). Financial incentives led to decreased consents and elicited strong rejections and negative reactions of the participants. Taking money for consent to organ donation seems to be a strict taboo for most people in Austrian society.

What English Language Learners Have to Say about NCLB Testing

ERIC Educational Resources Information Center

Yee, Mary

2015-01-01

This study constitutes the secondary analysis of data collected as part of classroom instruction in a prior practitioner inquiry study. Consequently, IRB approval, parental consent, and participant assent for the present study were obtained after the conclusion of the original study.

Health Literacy among Parents of Pediatric Patients

PubMed Central

Tran, T. Paul; Robinson, Laura M.; Keebler, John R.; Walker, Richard A.; Wadman, Michael C.

2008-01-01

Background Health literacy is an important predictor of healthcare outcomes, but research on this topic has largely been absent from the emergency medicine literature. Objective We measured the prevalence of health literacy in parents or guardians of pediatric patients seen in the emergency department (ED). Methods This was an observational study conducted in a Midwestern urban, university-based, tertiary, Level 1 trauma center ED with 33,000 visits/year. Using convenience sampling during a three-month period, English-speaking parents or guardians of pediatric patients (< 19 yrs.) were asked to complete the short version of the Test of Functional Health Literacy for Adults (s-TOFHLA). Parents/guardians were excluded if they had uncorrected visual impairment, required an interpreter, had altered mental status, or if the patients they accompanied were the subjects of a medical or trauma activation. Results Of the 188 parents or guardians approached, six did not consent or withdrew, one was excluded, leaving 181 (96.3%) in the study. Of these, 19 (10.5%) had either “marginal” or “inadequate” health literacy, while 162 (89.5%, 95% CI: 84.1%, 93.6%) had “adequate” health literacy. Conclusion A large majority (89.5%) of English-speaking parents or guardians of pediatric patients evaluated in the ED have adequate health literacy. This data may prompt ED professionals to adjust their communication styles in the evaluation of children. Future multi-center studies are needed to confirm the findings in this pilot study. PMID:19561727

Physician Knowledge and Attitudes around Confidential Care for Minor Patients.

PubMed

Riley, Margaret; Ahmed, Sana; Reed, Barbara D; Quint, Elisabeth H

2015-08-01

Minor adolescent patients have a legal right to access certain medical services confidentially without parental consent or notification. We sought to assess physicians' knowledge of these laws, attitudes around the provision of confidential care to minors, and barriers to providing confidential care. An anonymous online survey was sent to physicians in the Departments of Family Medicine, Internal Medicine-Pediatrics, Obstetrics/Gynecology, and Pediatrics at the University of Michigan. Response rate was 40% (259/650). The majority of physicians felt comfortable addressing sexual health, mental health, and substance use with adolescent patients. On average, physicians answered just over half of the legal knowledge questions correctly (mean 56.6% ± 16.7%). The majority of physicians approved of laws allowing minors to consent for confidential care (90.8% ± 1.7% approval), while substantially fewer (45.1% ± 4.5%) approved of laws allowing parental notification of this care at the physician's discretion. Most physicians agreed that assured access to confidential care should be a right for adolescents. After taking the survey most physicians (76.6%) felt they needed additional training on confidentiality laws. The provision of confidential care to minors was perceived to be most inhibited by insurance issues, parental concerns/relationships with the family, and issues with the electronic medical record. Physicians are comfortable discussing sensitive issues with adolescents and generally approve of minor consent laws, but lack knowledge about what services a minor can access confidentially. Further research is needed to assess best methods to educate physicians about minors' legal rights to confidential healthcare services. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

A Population-Based Evaluation of a Publicly Funded, School-Based HPV Vaccine Program in British Columbia, Canada: Parental Factors Associated with HPV Vaccine Receipt

PubMed Central

Ogilvie, Gina; Anderson, Maureen; Marra, Fawziah; McNeil, Shelly; Pielak, Karen; Dawar, Meena; McIvor, Marilyn; Ehlen, Thomas; Dobson, Simon; Money, Deborah; Patrick, David M.; Naus, Monika

2010-01-01

Background Information on factors that influence parental decisions for actual human papillomavirus (HPV) vaccine receipt in publicly funded, school-based HPV vaccine programs for girls is limited. We report on the level of uptake of the first dose of the HPV vaccine, and determine parental factors associated with receipt of the HPV vaccine, in a publicly funded school-based HPV vaccine program in British Columbia, Canada. Methods and Findings All parents of girls enrolled in grade 6 during the academic year of September 2008–June 2009 in the province of British Columbia were eligible to participate. Eligible households identified through the provincial public health information system were randomly selected and those who consented completed a validated survey exploring factors associated with HPV vaccine uptake. Bivariate and multivariate analyses were conducted to calculate adjusted odds ratios to identify the factors that were associated with parents' decision to vaccinate their daughter(s) against HPV. 2,025 parents agreed to complete the survey, and 65.1% (95% confidence interval [CI] 63.1–67.1) of parents in the survey reported that their daughters received the first dose of the HPV vaccine. In the same school-based vaccine program, 88.4% (95% CI 87.1–89.7) consented to the hepatitis B vaccine, and 86.5% (95% CI 85.1–87.9) consented to the meningococcal C vaccine. The main reasons for having a daughter receive the HPV vaccine were the effectiveness of the vaccine (47.9%), advice from a physician (8.7%), and concerns about daughter's health (8.4%). The main reasons for not having a daughter receive the HPV vaccine were concerns about HPV vaccine safety (29.2%), preference to wait until the daughter is older (15.6%), and not enough information to make an informed decision (12.6%). In multivariate analysis, overall attitudes to vaccines, the impact of the HPV vaccine on sexual practices, and childhood vaccine history were predictive of parents having a daughter receive the HPV vaccine in a publicly funded school-based HPV vaccine program. By contrast, having a family with two parents, having three or more children, and having more education was associated with a decreased likelihood of having a daughter receive the HPV vaccine. Conclusions This study is, to our knowledge, one of the first population-based assessments of factors associated with HPV vaccine uptake in a publicly funded school-based program worldwide. Policy makers need to consider that even with the removal of financial and health care barriers, parents, who are key decision makers in the uptake of this vaccine, are still hesitant to have their daughters receive the HPV vaccine, and strategies to ensure optimal HPV vaccine uptake need to be employed. Please see later in the article for the Editors' Summary PMID:20454567

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

PubMed Central

de Laat, Sonya; Schwartz, Lisa

2016-01-01

Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines. PMID:27625066

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

PubMed

Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

2016-01-01

Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN60695184 (date of registration: 13 May 2009), ISRCTN80061723 (date of registration: 8 March 2010), ISRCTN69423238 (date of registration: 18 November 2010).

A resolution designating November 8, 2012, as "National Parents as Teachers Day".

THOMAS, 112th Congress

Sen. Blunt, Roy [R-MO

2012-09-19

Senate - 09/19/2012 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Urine testing for drugs of abuse: a survey of suburban parent-adolescent dyads.

PubMed

Schwartz, Richard H; Silber, Tomas J; Heyman, Richard B; Sheridan, Michael J; Estabrook, Dawn M

2003-02-01

The American Academy of Pediatrics is opposed to involuntary diagnostic testing for drugs of abuse. To gather data about attitudes of parents and their teenagers about involuntary drug testing on parental request. Adolescents and their accompanying parents separately answered a printed survey in the offices of their private pediatrician. The survey posed 2 hypothetical questions about urine testing: (1) Do parents have the right to ask a teenager's physician to order a urine test for drugs of abuse without the teenager's knowledge-if the teenager has falling school grades, an uncooperative attitude, and major untruthfulness? (2) In such a case, should the teenager's physician obtain a urine test for drugs on parental request only, without the teenager's consent? A total of 393 paired evaluable surveys were collected: 77.6% from Virginia and 22.4% from Ohio. There were no significant differences in answers between the 2 study sites. Of the students, 85.8% had either an A or a B grade point average. Current marijuana use was unusually low in our teenaged respondents. Of the parents surveyed, 81.7% would want a physician to be able to perform a urine test for drugs of abuse for a problematic teenager without the young person's consent. The answers to the 2 questions about urine drug tests had poor kappa coefficients of agreement between teenagers and parents (0.04 and 0.09, respectively). Reanalysis, using the variables of age, grade point average, and frequency of marijuana smoking, showed little difference in agreement scores. In the 2 suburban pediatric practices surveyed, parental opinions and expectations were at variance with the American Academy of Pediatrics policy statement on nonconsensual urine drug testing in the presence of clinical problems. Pediatricians need to be conscious of this clinical-ethical dilemma, become familiar with the American Academy of Pediatrics policy on drug testing, and develop their own position and expertise in this area. The dyad method (parent-teenager survey) is novel and improved the methodology of our study. We surveyed middle-class suburban adolescents while previous studies of adolescents surveyed inner-city populations.

Use of Mobile Devices and the Internet for Multimedia Informed Consent Delivery and Data Entry in a Pediatric Asthma Trial: Study Design and Rationale

PubMed Central

Blake, Kathryn; Holbrook, Janet T.; Antal, Holly; Shade, David; Bunnell, H. Timothy; McCahan, Suzanne M.; Wise, Robert A.; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

2015-01-01

Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial. Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Results Participants have been enrolled in the streamlined and traditional trials and recuitment is ongoing. Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. PMID:25847579

Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

PubMed

Blake, Kathryn; Holbrook, Janet T; Antal, Holly; Shade, David; Bunnell, H Timothy; McCahan, Suzanne M; Wise, Robert A; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

2015-05-01

Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. Copyright © 2015 Elsevier Inc. All rights reserved.

Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

PubMed

Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

2014-02-01

Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups.

PubMed

Chamberlain, James M; Lillis, Kathleen; Vance, Cheryl; Brown, Kathleen M; Fawumi, Olubunmi; Nichols, Shari; Davis, Colleen O; Singh, Tasmeen; Baren, Jill M

2009-08-01

The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances. The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions. Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research. From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.

Legal and Ethical Considerations in Allowing Parental Exemptions From Newborn Critical Congenital Heart Disease (CCHD) Screening.

PubMed

Hom, Lisa A; Silber, Tomas J; Ennis-Durstine, Kathleen; Hilliard, Mary Anne; Martin, Gerard R

2016-01-01

Critical congenital heart disease (CCHD) screening is rapidly becoming the standard of care in the United States after being added to the Recommended Uniform Screening Panel (RUSP) in 2011. Newborn screens typically do not require affirmative parental consent. In fact, most states allow parents to exempt their baby from receiving the required screen on the basis of religious or personally held beliefs. There are many ethical considerations implicated with allowing parents to exempt their child from newborn screening for CCHD. Considerations include the treatment of religious exemptions in our current legal system, as well as medical and ethical principles in relation to the rights of infants. Although there are significant benefits to screening newborns for CCHD, when a parent refuses for religious or personal beliefs, in the case of CCHD screening, the parental decision should stand.

Abortion.

PubMed

1993-05-01

The Alan Guttmacher Institute's State Reproductive Health Monitor "Legislative Proposals and Actions" provides US legislative information on abortion. The listing contains information on pending bills: the state, the identifying legislative number, the sponsor, the committee, the date the bill was introduced, a description of the bill, and when available the bill's status. The bills cover: 1) clinic licensing, e.g., requiring outpatient health care facilities in which abortions are performed, to have malpractice liability insurance; 2) comprehensive statues, which require parental notification before minor may obtain abortions, mandate abortion counseling to all women 24 hours before the abortion can be performed and prohibit disciplining or discharging a state employee for refusing to provide abortion counseling; 3) fetal personhood and rights, e.g. providing that life is vested in each person at fertilization; 4) fetal research and remains; 5) gender of fetus, which regulate abortions relative to sex selection in pregnancies; 6) harassment regulation; 7) informed consent and waiting periods detailing the risks and alternatives to abortion, and the 24-hour waiting period; 8) insurance coverage, e.g., eliminating language banning the coverage of abortions for state workers, and prohibiting disclosure by a health insurance carrier to the employer of a claimant that the claimant had a surgical abortion; 9) legality of abortion, urging Congress to reject he Freedom of Choice Act; 10) parental consent and notification; 11) postviability requirements; 12) public funding; 13) reporting requirements; 14) reproductive rights, and 15) spousal and paternal consent and notification.

Breaking down barriers to communicating complex retinoblastoma information: can graphics be the solution?

PubMed

Chiu, Hannah H; Dimaras, Helen; Downie, Rob; Gallie, Brenda

2015-06-01

To investigate the impact of a graphical timeline summarizing bilateral retinoblastoma disease and treatment outcomes on parents' understanding of complex medical information. Cross-sectional survey. Parents of children with retinoblastoma who were being actively managed at The Hospital for Sick Children were recruited. Forty-five parents from 42 families participated. After a standardized presentation on retinoblastoma and visual tool named Disease-Specific electronic Patient Illustrated Clinical Timeline (DePICT), parents completed a 19-item questionnaire designed to assess their understanding of treatment choices for 2 eyes in bilateral retinoblastoma as communicated using DePICT. SPSS was used to perform statistical analysis. Forty-five parents from 42 families participated (65% female). Median age of participants was 34 years. Median level of participant education was completion of college/trade school. The median level of annual income was $40,000 to $70,000 CDN. Median time since diagnosis of retinoblastoma in their child was 13.5 months. Twenty-three (51%) participants were parents of children with unilateral retinoblastoma, and 22 (49%) were parents of children with bilateral retinoblastoma. Median number of correct answers was 15 of 19, and mean score was 77%. Normal distribution of scores was noted. English as a first language was significantly associated with score (p = 0.01). No significant association was observed between other variables and score in all analyses. This study builds on the validation of DePICT by demonstrating that parents can achieve good comprehension even when considering choices for treatment for 2 eyes with bilateral retinoblastoma. Clinical application of this tool can enhance the consent process. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Preoperative parental information and parents' presence at induction of anaesthesia.

PubMed

Astuto, M; Rosano, G; Rizzo, G; Disma, N; Raciti, L; Sciuto, O

2006-06-01

Preoperative preparation of paediatric patients and their environment in order to prevent anxiety is an important issue in paediatric anaesthesia. Anxiety in paediatric patients may lead to immediate negative postoperative responses. When a child undergoes surgery, information about the child's anaesthesia must be provided to parents who are responsible for making informed choices about healthcare on their child's behalf. A combination of written, pictorial, and verbal information would improve the process of informed consent. The issue of parental presence during induction of anaesthesia has been a controversial topic for many years. Potential benefits from parental presence at induction include reducing or avoiding the fear and anxiety that might occur in both the child and its parents, reducing the need for preoperative sedatives, and improving the child's compliance even if other studies showed no effects on the anxiety and satisfaction level. The presence of other figures such as clowns in the operating room, together with one of the child's parents, is an effective intervention for managing child and parent anxiety during the preoperative period.

Medical Rights of Minors: Some Answered and Unanswered Legal Questions.

ERIC Educational Resources Information Center

Talbutt, Lou

1980-01-01

Because school counselors work with minors they must keep up with current laws, as well as state and local school policies. Special caution is needed concerning medical rights of minors and parental consent in dealing with student pregnancy, abortion, drug abuse, and child abuse. (JAC)

Differences in adolescent dietary behaviors by SES

USDA-ARS?s Scientific Manuscript database

Little is known about how socioeconomic status (SES) affects dietary intake among adolescents. This study assessed whether dietary behaviors of 12- to 17-year-old adolescents differed by SES, using eligibility for free or reduced price (FRP) school meals as a measure of SES. After parental consent w...

Active choice but not too active: Public perspectives on biobank consent models

PubMed Central

Simon, Christian M.; L’Heureux, Jamie; Murray, Jeffrey C.; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget

2013-01-01

Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result. PMID:21555942

"...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials – assessment of understanding, appreciation and reasoning

PubMed Central

Koelch, Michael; Singer, Hanneke; Prestel, Anja; Burkert, Jessica; Schulze, Ulrike; Fegert, Jörg M

2009-01-01

Background The aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined. Methods Using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR. Results Facts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school. Conclusion Legal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships. PMID:19175905

Intervention effects on physical activity: the HEIA study - a cluster randomized controlled trial.

PubMed

Grydeland, May; Bergh, Ingunn Holden; Bjelland, Mona; Lien, Nanna; Andersen, Lene Frost; Ommundsen, Yngvar; Klepp, Knut-Inge; Anderssen, Sigmund Alfred

2013-02-05

Although school-based interventions to promote physical activity in adolescents have been suggested in several recent reviews, questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective. The aim of the present study was to investigate effects of a school-based intervention program: the HEalth in Adolescents (HEIA) study, on change in physical activity, and furthermore, to explore whether potential effects varied by gender, weight status, initial physical activity level and parental education level. This was a cluster randomized controlled 20 month intervention study which included 700 11-year-olds. Main outcome-variable was mean count per minute (cpm) derived from ActiGraph accelerometers (Model 7164/GT1M). Weight and height were measured objectively. Adolescents reported their pubertal status in a questionnaire and parents reported their education level on the consent form. Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school. The present study showed an intervention effect on overall physical activity at the level of p=0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group (95% CI -0.4, 100). Subgroup analyses showed that the effect appeared to be more profound among girls (Est 65 cpm, CI 5, 124, p=0.03) and among participants in the low-activity group (Est 92 cpm, CI 41, 142, p<0.001), as compared to boys and participants in the high-activity group, respectively. Furthermore, the intervention affected physical activity among the normal weight group more positively than among the overweight, and participants with parents having 13-16 years of education more positively than participants with parents having either a lower or higher number of years of education. The intervention seemed to succeed in reducing time spent sedentary among girls but not among boys. A comprehensive but feasible, multi-component school-based intervention can affect physical activity patterns in adolescents by increasing overall physical activity. This intervention effect seemed to be more profound in girls than boys, low-active adolescents compared to high-active adolescents, participants with normal weight compared to the overweight, and for participants with parents of middle education level as opposed to those with high and low education levels, respectively. An implementation of the HEIA intervention components in the school system may have a beneficial effect on public health by increasing overall physical activity among adolescents and possibly among girls and low-active adolescents in particular.

Risk perception and decision processes underlying informed consent to research participation.

PubMed

Reynolds, William W; Nelson, Robert M

2007-11-01

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

PubMed Central

2011-01-01

Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Conclusion Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. PMID:21943406

45 CFR 211.14 - Disclosure of information.

Code of Federal Regulations, 2010 CFR

2010-10-01

...), ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES CARE AND TREATMENT OF MENTALLY ILL NATIONALS OF THE UNITED STATES, RETURNED FROM FOREIGN COUNTRIES § 211.14 Disclosure of information..., if any (or, if he is a minor, his parent or legal guardian), shall consent; (2) As disclosure may be...

34 CFR 303.420 - Parental consent and ability to decline services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... decline any early intervention service under this part at any time, in accordance with State law; and (2...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... conducted under § 303.321; (3) Early intervention services are provided to the child under this part; (4...

34 CFR 303.420 - Parental consent and ability to decline services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... decline any early intervention service under this part at any time, in accordance with State law; and (2...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... conducted under § 303.321; (3) Early intervention services are provided to the child under this part; (4...

34 CFR 303.420 - Parental consent and ability to decline services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... decline any early intervention service under this part at any time, in accordance with State law; and (2...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... conducted under § 303.321; (3) Early intervention services are provided to the child under this part; (4...

Teenage Pregnancy: Issues and Strategies for School Counselors.

ERIC Educational Resources Information Center

Rolle, George E.; And Others

Many school administrators view teenage pregnancy as a top problems facing their school systems. Programs designed to reduce the teenage pregnancy rate must address multiple factors connected with teenage pregnancy. School-based clinic programs provide comprehensive primary health care for low income youth, require parental consent, provide mental…

Closing an Opportunity Gap: How a Modest Program Made a Difference

ERIC Educational Resources Information Center

Miretzky, Debra; Chennault, Ronald E.; Fraynd, Donald J.

2016-01-01

Chicago Public Schools and school districts throughout the country are seeking new ways to foster racial, ethnic, and socioeconomic equity as desegregation consent decrees are being lifted. One of Chicago's selective enrollment high schools drafted parents, educators, administrators, and community representatives to address its own diversity…

28 CFR 540.63 - Personal interviews.

Code of Federal Regulations, 2010 CFR

2010-07-01

... juvenile (under age 18) and written consent has not been obtained from the inmate's parent or guardian. If... persons (including competency commitments under 18 U.S.C. 4244 and 4246) held in federal institutions... of audio, video, and film equipment or number of media personnel entering the institution if the...

28 CFR 540.63 - Personal interviews.

Code of Federal Regulations, 2014 CFR

2014-07-01

... juvenile (under age 18) and written consent has not been obtained from the inmate's parent or guardian. If... persons (including competency commitments under 18 U.S.C. 4244 and 4246) held in federal institutions... of audio, video, and film equipment or number of media personnel entering the institution if the...

28 CFR 540.63 - Personal interviews.

Code of Federal Regulations, 2012 CFR

2012-07-01

... juvenile (under age 18) and written consent has not been obtained from the inmate's parent or guardian. If... persons (including competency commitments under 18 U.S.C. 4244 and 4246) held in federal institutions... of audio, video, and film equipment or number of media personnel entering the institution if the...

28 CFR 540.63 - Personal interviews.

Code of Federal Regulations, 2011 CFR

2011-07-01

... juvenile (under age 18) and written consent has not been obtained from the inmate's parent or guardian. If... persons (including competency commitments under 18 U.S.C. 4244 and 4246) held in federal institutions... of audio, video, and film equipment or number of media personnel entering the institution if the...

28 CFR 540.63 - Personal interviews.

Code of Federal Regulations, 2013 CFR

2013-07-01

... juvenile (under age 18) and written consent has not been obtained from the inmate's parent or guardian. If... persons (including competency commitments under 18 U.S.C. 4244 and 4246) held in federal institutions... of audio, video, and film equipment or number of media personnel entering the institution if the...

Alpha Test of a Videogame to Increase Children's Vegetable Consumption.

PubMed

Beltran, Alicia; O'Connor, Teresia; Hughes, Sheryl; Baranowski, Janice; Nicklas, Theresa A; Thompson, Debbe; Baranowski, Tom

2012-06-01

This is a report of an alpha test with a computer of one episode of a casual videogame smartphone application, called Kiddio Food Fight™ (Archimage Inc., Houston, TX), targeted at training parents to increase their 3-5-year-old child's vegetable consumption. This was a qualitative study using semistructured interviews. Sixteen parents from three ethnic groups living with their 3-5-year-old child were recruited. Parents provided screening information and informed consent and played the videogame. Afterward, semistructured intensive interviews were conducted about their experience. Parents generally liked the game. Their suggestions included a reduced list of values, rewording of reasons statements, an improved storyline, and feedback during and at the end of the game. The scoring system was ignored or confusing. Problems with the tool bar and game navigation caused problems in performance. A tutorial was requested. Kiddio Food Fight could have positive acceptance among parents with minor modifications. A videogame play could help parents learn effective vegetable parenting practices.

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

PubMed

Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

2015-10-01

The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers both to the health professional's obligation of information disclosure to the patient and to the quality of the patient's understanding and decision making. In other words, it does not refer to the single moment of the agreement, but to the whole complex process of gaining information, deciding and consenting. Several factors may restrict informed consent, including the patient's competence, provision of limited information, ineffective communication between patients and professionals, the hospital environment itself and privacy problems.According to the World Health Organization (WHO), people are increasingly urged to make choices for themselves or for their family members in regards to health care use. However, at the same time, inadequate or problematic health literacy skills have been reported in approximately half of the adult population in eight European countries. "Health literacy is linked to literacy and entails people's knowledge, motivation and competences to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course". There are many instruments measuring either health literacy in general or some dimensions of health literacy (e.g. numeracy), health literacy related to specific issues (e.g. nutrition, diabetes) or health literacy of specific populations (e.g. adolescents). The diversity of existing instruments, which includes diversity in terms of scoring and ranges, makes the comparison of the results of different studies difficult. Index thresholds and ranges for different levels of health literacy for most tools were set based either on that of other well established health literacy instruments used in the same study, or on experts' assessments of the required health literacy scores. Adequate health literacy could be considered as the capacity of successfully completing most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions designed to reduce the effects of limited health literacy in general. Some of the outcomes of the included studies were comprehension and behavioral intent, outcomes which could be strongly related to the informed consent process. Without making any distinction of the studies referring to the informed consent process, they conclude that several health literacy interventions, for example, adding video to narrative, could improve an individual's comprehension. Schenker et al. conducted a systematic review on the interventions to improve patient comprehension of medical and surgical procedures, including articles published until 2008. One of their conclusions was that, in most studies, while particular attention is needed for interventions provided to patients with limited literacy, the literacy of the patients was not addressed or assessed.Since then, many articles on health literacy and informed consent have been published. According to a recent review on best practices and new models of health literacy for informed consent, which includes papers published from 2004 to 2014, over half of the collected articles were published since 2010. This review, which is limited to literature within the US and its territories, and does not focus on the evaluation of the recommended practices in the literature, concludes that different tactics for simplifying written documents and clarifying verbal exchanges, and the use of multimedia formats and computerized exchanges might ameliorate constraints to health literate communications required for informed consent.Studies have evaluated the effectiveness of health literacy interventions which aim to improve the informed consent process. Improvement of the informed consent process may refer not only to the patients' comprehension but also, for example, to the recall of the information provided, to their intention to ask for clarifications, or to their satisfaction with the procedure. Interventions described and tested in the literature focus on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 9 2013-01-01 2013-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 10 2014-01-01 2014-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 9 2012-01-01 2012-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

Feasibility trial evaluation of a physical activity and screen-viewing course for parents of 6 to 8 year-old children: Teamplay

PubMed Central

2013-01-01

Background Many children spend too much time screen-viewing (watching TV, surfing the internet and playing video games) and do not meet physical activity (PA) guidelines. Parents are important influences on children’s PA and screen-viewing (SV). There is a shortage of parent-focused interventions to change children’s PA and SV. Methods Teamplay was a two arm individualized randomized controlled feasibility trial. Participants were parents of 6–8 year old children. Intervention participants were invited to attend an eight week parenting program with each session lasting 2 hours. Children and parents wore an accelerometer for seven days and minutes of moderate-to-vigorous intensity PA (MVPA) were derived. Parents were also asked to report the average number of hours per day that both they and the target child spent watching TV. Measures were assessed at baseline (time 0) at the end of the intervention (week 8) and 2 months after the intervention had ended (week 16). Results There were 75 participants who provided consent and were randomized but 27 participants withdrew post-randomization. Children in the intervention group engaged in 2.6 fewer minutes of weekday MVPA at Time 1 but engaged in 11 more minutes of weekend MVPA. At Time 1 the intervention parents engaged in 9 more minutes of weekday MVPA and 13 more minutes of weekend MVPA. The proportion of children in the intervention group watching ≥ 2 hours per day of TV on weekend days decreased after the intervention (time 0 = 76%, time 1 = 39%, time 2 = 50%), while the control group proportion increased slightly (79%, 86% and 87%). Parental weekday TV watching decreased in both groups. In post-study interviews many mothers reported problems associated with wearing the accelerometers. In terms of a future full-scale trial, a sample of between 80 and 340 families would be needed to detect a mean difference of 10-minutes of weekend MVPA. Conclusions Teamplay is a promising parenting program in an under-researched area. The intervention was acceptable to parents, and all elements of the study protocol were successfully completed. Simple changes to the trial protocol could result in more complete data collection and study engagement. PMID:23510646

Minors' rights in medical decision making.

PubMed

Hickey, Kathryn

2007-01-01

In the past, minors were not considered legally capable of making medical decisions and were viewed as incompetent because of their age. The authority to consent or refuse treatment for a minor remained with a parent or guardian. This parental authority was derived from the constitutional right to privacy regarding family matters, common law rule, and a general presumption that parents or guardians will act in the best interest of their incompetent child. However, over the years, the courts have gradually recognized that children younger than 18 years who show maturity and competence deserve a voice in determining their course of medical treatment. This article will explore the rights and interests of minors, parents, and the state in medical decision making and will address implications for nursing administrators and leaders.

Using digital multimedia to improve parents' and children's understanding of clinical trials.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Levine, Robert

2015-06-01

Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation. Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Association between Cariogenic Factors and the Occurrence of Early Childhood Caries in Children from Salem District of India.

PubMed

Stephen, Arokiaraj; Krishnan, Ramesh; Chalakkal, Paul

2017-07-01

Various aetiological factors for Early Childhood Caries (ECC) have been suggested in literature, but the role of each factor has been disputed in various studies. To evaluate the association between ECC and its related factors in children between three to six years of age, from rural, semi-urban and urban schools in the district of Salem (India). The study consisted of children between three to six years of age, selected randomly from schools in semi-urban, urban and rural schools at Salem. Questionnaire (comprising of the factors associated with ECC) and parental consent forms were sent to each of the parents of the school children. Filled questionnaires and parental consent forms were obtained from a total of 2771 children, out of which 1771 were boys and 1000 were girls. Clinical examination for ECC was carried out according to the WHO criteria, by a single examiner and an assistant to eliminate inter-examiner variability. Statistical analysis was carried out using the student's independent t-test and ANOVA (one way analysis of variance). Out of a total of 2771 children examined, only 443 (315 boys and 128 girls) children were found to have ECC (16 %). Significant correlations were found between the occurrence of ECC and various factors like age of parents, number of siblings, on-demand breast feeding and bottle feeding habits and sweetened pacifier use. However, factors such as age and gender of the child, type of birth and duration of pregnancy, had no significant correlation with the occurrence of ECC. The need for educating parents on the ill effects of improper breast feeding and bottle feeding habits is important.

Comparing abstract numerical and visual depictions of risk in survey of parental assessment of risk in sickle cell hydroxyurea treatment.

PubMed

Patterson, Chavis A; Barakat, Lamia P; Henderson, Phyllis K; Nall, Faith; Westin, Anna; Dampier, Carlton D; Hsu, Lewis L

2011-01-01

Communicating risk is an important activity in medical decision-making; yet, numeracy is not a universal skill among the American public. We examined the hypothesis that numerical risk information about the use of hydroxyurea for children with sickle cell disease would elicit different risk assessment responses when visual depictions were used instead of abstract numbers and depending on the disease severity. Parents of 81 children with sickle cell disease participated in a survey in which hydroxyurea was first described as carrying a certain chance of risk for both birth defects and cancer. Then, the parents indicated the highest risk at which they would hypothetically consent to the treatment to help their child. Risk presentations were repeated with abstract numerical, pie graph, and 1000 people histogram formats. The χ analyses comparing high-risk to low-risk assessment across presentation formats showed high consistency between visual depictions but low consistency of abstract numerical with visual depictions. The parents of children with SC and other less severe types of SCD were less willing to accept higher risk than those with SS when the data were presented numerically. Given earlier concerns about poor "numeracy" in the US population, visual depictions of risk could be an effective tool for routine communication in health education and medical decision-making.

Associations between general parenting styles and specific food-related parenting practices and children's food consumption.

PubMed

Vereecken, Carine; Legiest, Erwin; De Bourdeaudhuij, Ilse; Maes, Lea

2009-01-01

Explore the impact of general parenting style and specific food-related parenting practices on children's dietary habits. Cross-sectional study of sixth graders and their parents. Data were gathered (in 2003) in 69 of 100 randomly selected elementary schools in Belgium. All sixth graders (N = 1957) were invited to participate; 82.4% of their parents gave consent and completed questionnaires, resulting in 1614 parent-child pairs. Children's consumption of breakfast, fruit, vegetables, soft drinks, and sweets was assessed by self-administered food frequency questionnaires. Parents completed questionnaires on sociodemographic characteristics, general parenting styles (authoritarian, authoritative, indulgent, or neglecting) and specific food-related parenting practices (pressure, reward, encouragement through negotiation, catering on children's demands, permissiveness, avoiding negative modeling, and praise). Logistic regression analyses were performed, with general parenting style and specific food-related parenting practices as predictors and dietary habits as dependent variables, controlling for sociodemographic characteristics and children's weight status. General parenting style did not show any significant impact on dietary habits. In contrast, the food-related parenting practice "encouragement through negotiation" showed a significant positive impact, whereas "pressure," "catering on demand," and "permissiveness" were practices with an unhealthy impact. Nutrition education programs that guide parents in firm but not coercive food parenting skills are likely to have a positive impact upon children's dietary habits.

Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India.

PubMed

Yousuf, R M; Fauzi, A R M; How, S H; Rasool, A G; Rehana, K

2007-06-01

Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals. A questionnaire-based cross sectional survey among doctors in the two tertiary care hospitals, one in Malaysia and the other in Kashmir, was performed. Awareness on informed consent was universal with "reasonable physician standard" as the most popular choice. As compared to doctors in Malaysia, doctors from Kashmir showed a tendency to reservedly disclose medical information (p-value equals 0.051) and withhold it, if it was deemed potentially harmful (p-value is less than 0.001) or requested so by relatives (p-value is less than 0.023). They also withheld some information from female patients (p-value is less than 0.001). When consent was refused despite needing lifesaving intervention, the majority of both respondents (73 percent versus 80 percent) considered intervention without consent to be justified. Respondents from Malaysia felt that parents could refuse treatment on their children's behalf on the basis of their beliefs (p-value is less than 0.001). Despite a very high awareness of informed consent, the model chosen reflected age-old medical paternalism. Doctors' opinions are accorded a larger role in clinical decision-making in Kashmir. The results emphasise the need for doctors to change their attitude and acknowledge the patient's autonomy, which is the basis of modern medical ethics, and yet still be aware of the cultural and religious views of the local population.

Ethical Issues Regarding Informed Consent for Minors for Space Tourism

NASA Astrophysics Data System (ADS)

Marsh, Melvin S.

2010-01-01

This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

PubMed

Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

2016-09-13

Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Individual rights over public good? The future of anthropometric monitoring of school children in the fight against obesity.

PubMed

Stubbs, Joanne M; Achat, Helen M

2009-02-02

Available evidence indicates that rates of childhood overweight and obesity have been increasing over the past two decades, but inconsistencies between study methods moderate the strength of this evidence. Concomitant health problems and associated costs make it imperative that primary prevention initiatives are introduced to combat the obesity epidemic. Fundamental to informed action is anthropometric monitoring, which if properly implemented will identify changes over time in specific populations to inform policies, practices and services aimed at prevention and treatment. Sample representativeness is essential for valid trend and prevalence data, but efforts to obtain population-based anthropometric data from school children with the required written parental consent have been thwarted by low participation rates. Notable improvements in participation rates when utilising opt-out consent, in which participation is assumed unless otherwise indicated, are evident from local as well as international studies. Opt-out consent can facilitate anthropometric monitoring, delivering a more informed, best-value-for-money response to the obesity epidemic. Health and education ethics committees need to acknowledge the benefits of opt-out consent for "low-risk" anthropometric measurement, which ultimately upholds the individual's rights.

Citizenship, Beneficence, and Informed Consent: The Ethics of Working in Mixed-Status Families

ERIC Educational Resources Information Center

Mangual Figueroa, Ariana

2016-01-01

This article draws from a 23-month ethnographic study conducted in mixed-status Mexican homes to detail the particular methodological concerns that arise when conducting research within these legally complex and vulnerable families. Specifically, the analysis illustrates when and why undocumented parents in one focal family asked the ethnographer…

The Effectiveness of Mandatory-Random Student Drug Testing

ERIC Educational Resources Information Center

James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric

2011-01-01

One approach some U.S. schools now use to combat high rates of adolescent substance use is school-based mandatory-random student drug testing (MRSDT). Under MRSDT, students and their parents sign consent forms agreeing to the students' participation in random drug testing as a condition of participating in athletics and other school-sponsored…

34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

Code of Federal Regulations, 2012 CFR

2012-07-01

... the following conditions: (1)(i)(A) The disclosure is to other school officials, including teachers... educational agency or institution or other party has made a reasonable determination that a student's identity... identity of parents, students, school officials, and any other parties to whom the agency or institution...

34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

Code of Federal Regulations, 2014 CFR

2014-07-01

... the following conditions: (1)(i)(A) The disclosure is to other school officials, including teachers... educational agency or institution or other party has made a reasonable determination that a student's identity... identity of parents, students, school officials, and any other parties to whom the agency or institution...

34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

Code of Federal Regulations, 2013 CFR

2013-07-01

... the following conditions: (1)(i)(A) The disclosure is to other school officials, including teachers... educational agency or institution or other party has made a reasonable determination that a student's identity... identity of parents, students, school officials, and any other parties to whom the agency or institution...

Research Disclosure Procedures for the Kamehameha Early Education Project. Technical Report #21.

ERIC Educational Resources Information Center

Omori, Sharon; And Others

This report describes research disclosure procedures and materials developed for the Kamehameha Early Education Program (KEEP) to fulfill the informed consent principle of the ethical guidelines of the American Psychological Association. A requirement for registration of children in the program is that parents attend one of two disclosure…

FERPA and Homelessness: A Technical Assistance Tool for NAEHCY Members

ERIC Educational Resources Information Center

National Association for the Education of Homeless Children and Youth, 2010

2010-01-01

The Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of student education records. Specifically, it prohibits a school from disclosing personally identifiable information from students' education records without the consent of a parent or eligible student, unless an exception to FERPA's general consent…

Characteristics and attitudes of parents of children born with the use of assisted reproductive technology.

PubMed

Braverman, A M; Boxer, A S; Corson, S L; Coutifaris, C; Hendrix, A

1998-11-01

To explore the medical issues, attitudes, concerns, and choices that parents have about their children born with the use of assisted reproductive technology (ART). Retrospective and prospective survey. An academic medical center and a private practice. Participants who conceived and were delivered of infants in two ART programs. A total of 373 patients were mailed an anonymous survey, a consent form, and the Parent Child Relationship Inventory. The rate of response was approximately 49% for clinic A and 33% for clinic B. Pregnancy outcomes and attitudes about parenting. Respondents' major concerns during pregnancy revolved around miscarriage and the infant's health; complications occurred in 38.9% of first pregnancies. Parents believed that their children were more appreciated, that their children were not emotionally different, that ART did not create ongoing medical or emotional problems, and they were not overprotective as parents. Gender differences were statistically significant on attitudinal variables. Parents had concerns about pregnancy. Overall, men and women felt positive about ART and their parenting. The ART experience is associated with complex choices, attitudes, and emotions.

The Human Tissue Act 2004 and the child donor.

PubMed

Baston, Jenny

2009-05-01

In 2001, the inquiry panel appointed to investigate the removal, retention and disposal of human organs and tissues at the Royal Liverpool Children's Hospital published its report. The panel's recommendations led to a new approach to consent for organ removal and storage under the new Human Tissue Act 2004. For child bone marrow donors, the new consent process requires all donor children or their parent to undergo a separate assessment before the bone marrow donation. They must be assessed by an accredited assessor who will submit a recommendation to the Human Tissue Authority for consideration. The unfortunate circumstances highlighted in the inquiry have led to changes to law, practice and culture that are benefiting other children and families.

Informed Consent to Treatment in Psychiatry

PubMed Central

Neilson, Grainne; Chaimowitz, Gary

2015-01-01

Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

The adoption of children from out-of-home care: The understandings of key decision makers in Victoria, Australia.

PubMed

Butlinski, Anna; Rowe, Heather; Goddard, Christopher; Freezer, Nicholas

2017-10-01

Adoption is one of a range of options that can provide children in out-of-home care with permanency when they are unable to be reunified with their birth parents. This paper reports on how the adoption of children from out-of-home care is understood by professionals involved in making decisions about the permanent placement of children in out-of-home care in Victoria, Australia, where adoption is rarely used. Data were collected through a single, face-to-face semi-structured interview with 21 professionals; eight child welfare specialists, eight adoption and permanent care specialists and five judicial officers. The adoption of children from out-of-home care was primarily understood as a child-centered practice that can afford children stability and a sense of belonging. Adoption was largely viewed as a voluntary process dependent upon the consent of a child's birth parents. Adoption and permanent care specialists were the only group to refer to the dispensation of parental consent as a means of obtaining an adoption order. Most decision makers understood that contact between children and their birth parents is possible following adoption, but this was not understood by all judicial officers or all child welfare specialists. Children's connection to their cultural heritage was viewed as important to the consideration of adoption for children in out-of-home care. This research provides insight into the foundations upon which decision makers may appraise adoption, within a hierarchy of options, as a potential outcome for children in need of permanency. Copyright © 2017 Elsevier Ltd. All rights reserved.

Parents as passengers during pediatric transport.

PubMed

Lewis, M M; Holditch-Davis, D; Brunssen, S

1997-01-01

The transport environment presents a unique setting in which the feasibility, advantages, and disadvantages of passengers accompanying a patient must be assessed carefully. The purpose of this study was to describe the current practice of including parents as passengers during pediatric interfacility transport. One-hundred-eighty-eight critical care transport programs in the United States responded to a voluntary mail survey, providing information about current policies, practices, and crew perceptions of the advantages and disadvantages of carrying parents as passengers. Extra seating for passengers was available in 96% of ambulances, 86% of fixed-wing aircraft, and 54% of helicopters used for pediatric transport. Parents traveled as passengers in all types of vehicles; most frequently in ambulances and fixed-wing aircraft. Twenty percent of helicopter programs allowed parent passengers on more than half of their pediatric transports in this vehicle. Advantages of parent passengers included emotional benefit for the parent and child, availability of parents for history and consent, good public relations, and having the parent present if the child dies. Disadvantages included potential parent anxiety, crew distraction, and space limitations. This study reflects the widely diverse policies, practices, and opinions relevant to this topic and confirms a need for further study.

Participation in clinical research: perspectives of adult patients and parents of pediatric patients undergoing hematopoietic stem cell transplantation.

PubMed

Keusch, Florian; Rao, Rohini; Chang, Lawrence; Lepkowski, James; Reddy, Pavan; Choi, Sung Won

2014-10-01

Despite major improvements over the past several decades, many patients undergoing hematopoietic stem cell transplantations (HSCT) continue to suffer from significant treatment-related morbidity and mortality. Clinical research studies (trials) have been integral to advancing the standard of care in HSCT. However, 1 of the biggest challenges with clinical trials is the low participation rate. Although barriers to participation in cancer clinical trials have been previously explored, studies specific to HSCT are lacking. The current study was undertaken to examine the knowledge, attitudes, and perceptions of HSCT patients regarding clinical trials. As members of focus groups, participants responded to open-ended questions that assessed factors influencing decision-making about HSCT clinical trials. Suggestions for improvements in the recruitment process were also solicited among participants. Seventeen adult HSCT patients and 6 parents of pediatric HSCT patients participated in the study. The median age was 56 years (range, 18 to 70) and 44 years (range, 28 to 54) for adult patients and parents, respectively. Participants universally indicated that too much information was provided within the informed consents and they were intimidated by the medical and legal language. Despite the large amount of information provided to them at the time of study enrollment, the participants had limited knowledge retention and recall of study details. Nevertheless, participants reported overall positive experiences with clinical trial participation and many would readily choose to participate again. A common concern among participants was the uncertainty of study outcome and general lack of feedback about results at the end of the study. Participants suggested that investigators provide more condensed and easier to understand informed consents and follow-up of study findings. These findings could be used to help guide the development of improved consent documents and enhanced participation in research studies, thereby affecting the future design of HSCT research protocols. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

The provision of birth control services to unwed minors: a national survey of physician attitudes and practices.

PubMed

Boldt, E D; Roberts, L W; Latif, A H

1982-01-01

A national survey was undertaken in an effort to assess physician attitudes and practices with regard to the provision of family planning to minors. The initial sample consisted of physicians in the 3 self-designated speciality areas: obstetrics/gynecology; family medicine; and internal medicine. The sampling frame of 4636 physicians was constructed from the Canadian Medical Directory, stratified by community size into 4 categories. A systematic random sample of 2318 physicians was selected. A total of 189 questionnaires could not be delivered. Of the remaining 2129, 1146 were completed and returned, a response rate of 54%. Almost all of the respondents were willing to provide information to most patients. The exception was single women under the age of majority, without parental consent. Only 82% indicated a definite willingness to provide this category of patient with the requested information. Although this is high in absolute terms, the figure is notably lower than for other categories. Whereas 82% of the respondents were prepared to provide the single minor patient with information, only 57% indicated an unqualified willingness to provide the requested services. 14% indicated that they would not provide such services; another 29% were equivocal. Physicians were asked to report the frequency with which they recommended and/or prescribed various birth control measures. There was an overwhelming preference for oral contraceptives (OCs), followed by IUDs and surgical methods, particularly tubal ligation. Legal considerations were the most pervasive deterrent to providing services to single women under the age of majority, without parental consent. The data indicate that a substantial proportion of physicians may not be discharging their responsibility effectively given their apparent reluctance to provide frequently requested contraceptive services to single female minors without parental consent. Only 9% of the physicians in the sample believed that they were adequately protected against legal liability should they provide services to women in this category. Both statute and common law are ambiguous on this point.

Children's views on research without prior consent in emergency situations: a UK qualitative study.

PubMed

Roper, Louise; Sherratt, Frances C; Young, Bridget; McNamara, Paul; Dawson, Angus; Appleton, Richard; Crawley, Esther; Frith, Lucy; Gamble, Carrol; Woolfall, Kerry

2018-06-09

We explored children's views on research without prior consent (RWPC) and sought to identify ways of involving children in research discussions. Qualitative interview study. Participants were recruited through a UK children's hospital and online advertising. 16 children aged 7-15 years with a diagnosis of asthma (n=14) or anaphylaxis (n=2) with recent (<12 months) experience of emergency care. Children were keen to be included in medical research and viewed RWPC as acceptable in emergency situations if trial interventions were judged safe. Children trusted that doctors would know about their trial participation and act in their best interests. All felt that children should be informed about the research following their recovery and involved in discussions with a clinician or their parent(s) about the use of data already collected as well as continued participation in the trial (if applicable). Participants suggested methods to inform children about their trial participation including an animation. Children supported, and were keen to be involved in, clinical trials in emergency situations. We present guidance and an animation that practitioners and parents might use to involve children in trial discussions following their recovery. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Outcomes From Pediatric Gastroenterology Maintenance of Certification Using Web-based Modules.

PubMed

Sheu, Josephine; Chun, Stanford; O'Day, Emily; Cheung, Sara; Cruz, Rusvelda; Lightdale, Jenifer R; Fishman, Douglas S; Bousvaros, Athos; Huang, Jeannie S

2017-05-01

Beginning in 2013, the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) sponsored and developed subspecialty field-specific quality improvement (QI) activities to provide Part 4 Maintenance of Certification (MOC) credit for ongoing certification of pediatric gastroenterologists by the American Board of Pediatrics. Each activity was a Web-based module that measured clinical practice data repeatedly over at least 3 months as participants implemented rapid cycle change. Here, we examine existing variations in clinical practice among participating pediatric gastroenterologists and determine whether completion of Web-based MOC activities improves patient care processes and outcomes. We performed a cross-sectional and prospective analysis of physician and parent-reported clinical practice data abstracted from Web-based MOC modules on the topics of upper endoscopy, colonoscopy, and informed consent collected from pediatric gastroenterologists from North America from 2013 to 2016. Among 134 participating pediatric gastroenterologists, 56% practitioners practiced at an academic institution and most (94%) were NASPGHAN members. Participating physicians reported data from 6300 procedures. At baseline, notable practice variation across measured activities was demonstrated. Much of the rapid cycle changes implemented by participants involved individual behaviors, rather than system/team-based improvement activities. Participants demonstrated significant improvements on most targeted process and quality care outcomes. Pediatric gastroenterologists and parents reported baseline practice variation, and improvement in care processes and outcomes measured during NASPGHAN-sponsored Web-based MOC QI activities. Subspecialty-oriented Web-based MOC QI activities can reveal targets for reducing unwarranted variation in clinical pediatric practice, and can effectively improve care and patient outcomes.

Ethics in studies on children and environmental health.

PubMed

Merlo, D F; Knudsen, L E; Matusiewicz, K; Niebrój, L; Vähäkangas, K H

2007-07-01

Children, because of age-related reasons, are a vulnerable population, and protecting their health is a social, scientific and emotional priority. The increased susceptibility of children and fetuses to environmental (including genotoxic) agents has been widely discussed by the scientific community. Children may experience different levels of chemical exposure than adults, and their sensitivity to chemical toxicities may be increased or decreased in comparison with adults. Such considerations also apply to unborn (fetal exposure) and newborn (neonatal exposure) children. Therefore, research on children is necessary in both clinical and environmental fields, to provide age-specific relevant data regarding the efficacy and safety of medical treatments, and regarding the assessment of risk from unintended environmental exposure. In this context, the stakeholders are many, including children and their parents, physicians and public health researchers, and the society as a whole, with its ethical, regulatory, administrative and political components. The important ethical issues are information of participants and consent to participate. Follow-up and protection of data (samples and information derived from samples) should be discussed in the context of biobanks, where children obtain individual rights when they become adults. It is important to realise that there are highly variable practices within European countries, which may have, in the past, led to differences in practical aspects of research in children. A number of recommendations are provided for research with children and environmental health. Environmental research with children should be scientifically justified, with sound research questions and valid study protocols of sufficient statistical power, ensuring the autonomy of the child and his/her family at the time of the study and later in life, if data and samples are used for follow-up studies. When children are enrolled, we recommend a consent dyad, including (1) parental (or legal guardian) informed consent and (2) the child's assent and/or informed consent from older minors. For evaluation of the studies including children, a paediatrician should always be involved in the research ethics committee.

Ethics in studies on children and environmental health

PubMed Central

Merlo, D F; Knudsen, L E; Matusiewicz, K; Niebrój, L; Vähäkangas, K H

2007-01-01

Children, because of age‐related reasons, are a vulnerable population, and protecting their health is a social, scientific and emotional priority. The increased susceptibility of children and fetuses to environmental (including genotoxic) agents has been widely discussed by the scientific community. Children may experience different levels of chemical exposure than adults, and their sensitivity to chemical toxicities may be increased or decreased in comparison with adults. Such considerations also apply to unborn (fetal exposure) and newborn (neonatal exposure) children. Therefore, research on children is necessary in both clinical and environmental fields, to provide age‐specific relevant data regarding the efficacy and safety of medical treatments, and regarding the assessment of risk from unintended environmental exposure. In this context, the stakeholders are many, including children and their parents, physicians and public health researchers, and the society as a whole, with its ethical, regulatory, administrative and political components. The important ethical issues are information of participants and consent to participate. Follow‐up and protection of data (samples and information derived from samples) should be discussed in the context of biobanks, where children obtain individual rights when they become adults. It is important to realise that there are highly variable practices within European countries, which may have, in the past, led to differences in practical aspects of research in children. A number of recommendations are provided for research with children and environmental health. Environmental research with children should be scientifically justified, with sound research questions and valid study protocols of sufficient statistical power, ensuring the autonomy of the child and his/her family at the time of the study and later in life, if data and samples are used for follow‐up studies. When children are enrolled, we recommend a consent dyad, including (1) parental (or legal guardian) informed consent and (2) the child's assent and/or informed consent from older minors. For evaluation of the studies including children, a paediatrician should always be involved in the research ethics committee. PMID:17601869

[Vaccination counselling: The meeting point is possible].

PubMed

Piñeiro Pérez, Roi; Hernández Martín, Diego; Carro Rodríguez, Miguel Ángel; de la Parte Cancho, María; Casado Verrier, Esther; Galán Arévalo, Sonsoles; Carabaño Aguado, Iván

2017-06-01

There are recommendations for decision-making as regards parents who do not vaccinate their children, but there are few publications analysing this problem. In November 2014, a pioneer medical clinic opened in Spain, for counselling on immunisation practices. The aim of this study is to determine the success of the recommendations of the American and Spanish Paediatrics Associations according to the number of parents who finally accept vaccination. A descriptive, cross-sectional, prospective and single-centre study was conducted from November 2014 to March 2016. Children under the age of 16 not properly vaccinated, according to the immunisation schedule of the region where the study was conducted, were included after signing informed consent. A total of 20 families were counselled. The median age of the children was 2 years, and 80% of them received no vaccine. Absolute non-acceptance of vaccination was practiced by 45% of parents. The main reasons for not vaccinating were: 100% thimerosal-containing, 90% risk of autism, 85% aluminium-containing, 70% presence of other stabilisers and preservatives, and 65% risk of anaphylaxis. The immunisation advice was said to be helpful by 90% of parents. Vaccination was accepted by 90% of parents (45% completely). Anti-vaccination ideologies are strong and hard to change. Paediatricians not denying medical care to parents who endanger the lives of their own children are also hard to find. The meeting point is possible, and society needs it. Active listening, empathy, and good quality information were the keys to our results. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Parental consent for bone marrow transplantation in the case of genetic disorders.

PubMed

Prows, C A; McCain, G C

1997-01-01

To describe the responses of mothers and fathers who were offered bone marrow transplantation (BMT) for their children with genetic disorders. Qualitative. Private hospital rooms/offices. Six mothers and 4 fathers of children with genetic disorders. The basic social-psychological problem confronting the parents was the conflicting alternatives of life versus death for their children. It was certain that these children would die from their genetic disorders but without having to endure the pain and suffering of a BMT. The BMT would be difficult, possibly resulting in death, but with a chance of survival. Parents believed that BMT was the only chance of survival for their children, leaving them no choice except to pursue the BMT treatment.

Best practice guidelines on informed consent for weight loss surgery patients.

PubMed

Sabin, James; Fanelli, Robert; Flaherty, Helen; Istfan, Nawfal; Mariner, Wendy; Barnes, Janet Nally; Pratt, Janey S A; Rossi, Laura; Samour, Patricia

2005-02-01

To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.

Intervention effects on physical activity: the HEIA study - a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Although school-based interventions to promote physical activity in adolescents have been suggested in several recent reviews, questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective. The aim of the present study was to investigate effects of a school-based intervention program: the HEalth in Adolescents (HEIA) study, on change in physical activity, and furthermore, to explore whether potential effects varied by gender, weight status, initial physical activity level and parental education level. Methods This was a cluster randomized controlled 20 month intervention study which included 700 11-year-olds. Main outcome-variable was mean count per minute (cpm) derived from ActiGraph accelerometers (Model 7164/GT1M). Weight and height were measured objectively. Adolescents reported their pubertal status in a questionnaire and parents reported their education level on the consent form. Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school. Results The present study showed an intervention effect on overall physical activity at the level of p = 0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group (95% CI −0.4, 100). Subgroup analyses showed that the effect appeared to be more profound among girls (Est 65 cpm, CI 5, 124, p = 0.03) and among participants in the low-activity group (Est 92 cpm, CI 41, 142, p < 0.001), as compared to boys and participants in the high-activity group, respectively. Furthermore, the intervention affected physical activity among the normal weight group more positively than among the overweight, and participants with parents having 13–16 years of education more positively than participants with parents having either a lower or higher number of years of education. The intervention seemed to succeed in reducing time spent sedentary among girls but not among boys. Conclusions A comprehensive but feasible, multi-component school-based intervention can affect physical activity patterns in adolescents by increasing overall physical activity. This intervention effect seemed to be more profound in girls than boys, low-active adolescents compared to high-active adolescents, participants with normal weight compared to the overweight, and for participants with parents of middle education level as opposed to those with high and low education levels, respectively. An implementation of the HEIA intervention components in the school system may have a beneficial effect on public health by increasing overall physical activity among adolescents and possibly among girls and low-active adolescents in particular. PMID:23379535

Impact of physical activity on energy balance, food intake and choice in normal weight and obese children in the setting of acute social stress: a randomized controlled trial.

PubMed

Horsch, Antje; Wobmann, Marion; Kriemler, Susi; Munsch, Simone; Borloz, Sylvie; Balz, Alexandra; Marques-Vidal, Pedro; Borghini, Ayala; Puder, Jardena J

2015-02-19

Psychological stress negatively influences food intake and food choices, thereby contributing to the development of childhood obesity. Physical activity can also moderate eating behavior and influence calorie intake. However, it is unknown if acute physical activity influences food intake and overall energy balance after acute stress exposure in children. We therefore investigated the impact of acute physical activity on overall energy balance (food intake minus energy expenditure), food intake, and choice in the setting of acute social stress in normal weight (NW) and overweight/obese (OW/OB) children as well as the impact of psychological risk factors. After receiving written consent from their parents, 26 NW (BMI < 90(th) percentile) and 24 7-to 11-year-old OW (n = 5)/OB (n = 19, BMI ≥ 90(th) percentile) children were randomly allocated using computer-generated numbers (1:1, after stratification for weight status) to acute moderate physical or to sedentary activity for 30 min. Afterwards, all children were exposed to an acute social stressor. Children and their parents completed self-report questionnaires. At the end of the stressor, children were allowed to eat freely from a range of 12 different foods (6 sweet/6 salty; each of low/high caloric density). Energy balance, food intake/choice and obesity-related psychological risk factors were assessed. Lower overall energy balance (p = 0.019) and a decreased choice of low density salty foods (p < 0.001) in NW children compared with OW/OB children was found after acute moderate physical activity but not sedentary activity. Independent of their allocation, OW/OB children ate more high density salty foods (104 kcal (34 to 173), p = 0.004) following stress. They scored higher on impulsive behavior (p = 0.005), restrained eating (p < 0.001) and parental corporal punishment (p = 0.03), but these psychological factors were not related to stress-induced food intake/choice. Positive parenting tended to be related to lower intake of sweet high density food (-132 kcal, -277 to 2, p = 0.054). In the setting of stress, acute moderate physical activity can address energy balance in children, a benefit which is especially pronounced in the OW/OB. Positive parenting may act as a protective factor preventing stress-induced eating of comfort food. clinicaltrials.gov NCT01693926 The study was a pilot study of a project funded by the Swiss National Science Foundation (CRSII3_147673).

[The reliability of a questionnaire regarding Colombian children's physical activity].

PubMed

Herazo-Beltrán, Aliz Y; Domínguez-Anaya, Regina

2012-10-01

Reporting the Physical Activity Questionnaire for school children's (PAQ-C) test-retest reliability and internal consistency. This was a descriptive study of 100 school-aged children aged 9 to 11 years old attending a school in Cartagena, Colombia. The sample was randomly selected. The PAQ-C was given twice, one week apart, after the informed consent forms had been signing by the children's parents and school officials. Cronbach's alpha coefficient of reliability was used for assessing internal consistency and an intra-class correlation coefficient for test-retest reliability SPSS (version 17.0) was used for statistical analysis. The questionnaire scored 0.73 internal consistencies during the first measurement and 0.78 on the second; intra-class correlation coefficient was 0.60. There were differences between boys and girls regarding both measurements. The PAQ-C had acceptable internal consistency and test-retest reliability, thereby making it useful for measuring children's self-reported physical activity and a valuable tool for population studies in Colombia.

78 FR 64423 - Children's Online Privacy Protection Rule Applications for Approval of Proposed Parental Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

..., Inc.; Application for Approval of Safe Harbor Program by kidSAFE Seal Program AGENCY: Federal Trade... kidSAFE Seal Program (``kidSAFE''), owned and operated by Samet Privacy, LLC, under the safe harbor... following the instructions on the web-based form. For comments concerning kidSAFE, write ``kidSAFE...

Pediatric Depression: When Does Parental Refusal for Treatment Constitute Medical Neglect?

PubMed

Shapiro, Michael

2018-06-01

Depression is a common disorder in youth, and 10% to 15% of individuals have a lifetime prevalence by 18 years of age. Youth who receive treatment typically have a positive outcome, but many remain undiagnosed and untreated. 1 There is a dearth of literature on parental refusal to consent to treatment for pediatric depression and the circumstances under which such refusal could be considered medical neglect. In general, it appears that mental health diagnoses are rarely reported in cases of medical neglect. 2 . Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries

PubMed Central

2010-01-01

Background Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results. Methods Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English. Results The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive information and return of results. In all studies, signs of child abuse require reports to authorities, but this disclosure duty is not always stated in consent materials. Studies vary in whether they will return to participants results of routine tests/measures, but none inform participants about findings with unknown clinical significance. Conclusions Analysis of how cohort studies in various jurisdictions handle key ELS issues provides informative data for comparison and contrast. Consideration of these and other examples and further scholarly exploration of ELS issues provides insight on how best to address these aspects in ways that respect the well-being of participants, especially children who become research subjects at the start of their lives. PMID:20331891

CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

EPA Science Inventory

The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

Exploring human papillomavirus vaccination refusal among ethnic minorities in England: A comparative qualitative study

PubMed Central

Rockliffe, Lauren; Marlow, Laura A.V.; Bedford, Helen; McBride, Emily; Waller, Jo

2017-01-01

Abstract Objectives In England, uptake of human papillomavirus (HPV) vaccination to prevent HPV‐related cancer is lower among girls from ethnic minority backgrounds. We aimed to explore the factors that prevented ethnic minority parents from vaccinating, compared to White British nonvaccinating parents and vaccinating ethnic minority parents. Methods Interviews with 33 parents (n = 14 ethnic minority non‐vaccinating, n = 10 White British nonvaccinating, and n = 9 ethnic minority vaccinating) explored parents' reasons for giving or withholding consent for HPV vaccination. Data were analysed using Framework Analysis. Results Concerns about the vaccine were raised by all nonvaccinating ethnic minority parents, and they wanted information to address these concerns. External and internal influences affected parents' decisions, as well as parents' perceptions that HPV could be prevented using means other than vaccination. Reasons were not always exclusive to nonvaccinating ethnic minority parents, although some were, including a preference for abstinence from sex before marriage. Only ethnic minority parents wanted information provided via workshops. Conclusions Ethnic differences in HPV vaccination uptake may be partly explained by concerns that were only reported by parents from some ethnic groups. Interventions to improve uptake may need to tackle difficult topics like abstinence from sex before marriage, and use a targeted format. PMID:28231418

78 FR 27404 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... submitted a proposed collection of information entitled ``Guidance on Informed Consent for In Vitro...

Bariatric surgery for obese children and adolescents: a review of the moral challenges.

PubMed

Hofmann, Bjørn

2013-04-30

Bariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent decision making process. A wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed. Performing bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents.

Bariatric surgery for obese children and adolescents: a review of the moral challenges

PubMed Central

2013-01-01

Background Bariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent decision making process. Discussion A wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed. Summary Performing bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents. PMID:23631445

Treatment for gender dysphoria in children: the new legal, ethical and clinical landscape.

PubMed

Smith, Malcolm K; Mathews, Ben

2015-02-02

Gender dysphoria is a condition in which a child's subjectively felt identity and gender are not congruent with her or his biological sex. Because of this, the child suffers clinically significant distress or impairment in social functioning. The Family Court of Australia has recently received an increasing number of applications seeking authorisation for the provision of hormones to treat gender dysphoria in children. Some medical procedures and interventions performed on children are of such a grave nature that court authorisation must be obtained to render them lawful. These procedures are referred to as special medical procedures. Hormonal therapy for the treatment of gender dysphoria in children is provided in two stages occurring years apart. Until recently, both stages of treatment were regarded by courts as special medical treatments, meaning court authorisation had to be provided for both stages. In a significant recent development, courts have drawn a distinction between the two stages of treatment, permitting parents to consent to the first stage. In addition, it has been held that a child who is determined by a court to be Gillick competent can consent to stage 2 treatment. The new legal developments concerning treatment for gender dysphoria are of ethical, clinical and practical importance to children and their families, and to medical practitioners treating children with gender dysphoria. Medical practitioners should benefit from an understanding of the recent developments in legal principles. This will ensure that they have up-to-date information about the circumstances under which treatment may be conducted with parental consent, and those in which they must seek court authorisation.

An Innovative Strategy to Improve Family-Infant Bonding.

PubMed

Hutcheson, Jamie L; Cheeseman, Susan E

2015-01-01

To improve family-infant bonding while newborns were separated from their parents, work began to develop a new Childbirth Center policy to guide staff in using Apple's FaceTime application with patients. Multidisciplinary meetings were held to obtain consent for the use of FaceTime and to protect patient information. We acquired two iPads and the support needed for updates. The staff was educated, and implementation began in January, 2014. This program improved bonding as evidenced by feedback received from the parents who utilized it. Several parents commented on how much they preferred seeing images of their babies in motion breathing and crying instead of just still pictures. Physicians also used FaceTime while talking with parents about plans of care. Since our implementation, we have utilized FaceTime with 46 infants to impact bonding in our Special Care nursery. This process enhances the delivery of relationship-based care with our patients.

Hodgson v. Minnesota.

PubMed

1990-06-25

Doctors, clinics, pregnant minors, and the mother of a pregnant minor filed suit in District Court to enjoin enforcement of Minnesota's abortion statute. The plaintiffs objected on due process and equal protection grounds to subdivisions of the statute mandating either that both parents of a minor be notified of her pending abortion, or, in lieu of two-parent notification, that a court authorize the abortion after determining that the minor is capable of giving informed consent. The District Court declared the entire statute unconstitutional. The Court of Appeals reversed, ruling that the provision for judicial bypass of the two-parent notification requirement was valid and saved the statute as a whole. In a 5-4 decision, the U.S. Supreme Court affirmed the Court of Appeals judgment. It concluded that while the two-parent notification requirement in itself violated the Constitution, the statute was rendered constitutional by the judicial bypass provision.

Gender differences in heterosexual college students' conceptualizations and indicators of sexual consent: implications for contemporary sexual assault prevention education.

PubMed

Jozkowski, Kristen N; Peterson, Zoë D; Sanders, Stephanie A; Dennis, Barbara; Reece, Michael

2014-01-01

Because sexual assault is often defined in terms of nonconsent, many prevention efforts focus on promoting the clear communication of consent as a mechanism to reduce assault. Yet little research has specifically examined how sexual consent is being conceptualized by heterosexual college students. In this study, 185 Midwestern U.S. college students provided responses to open-ended questions addressing how they define, communicate, and interpret sexual consent and nonconsent. The study aimed to assess how college students define and communicate consent, with particular attention to gender differences in consent. Results indicated no gender differences in defining consent. However, there were significant differences in how men and women indicated their own consent and nonconsent, with women reporting more verbal strategies than men and men reporting more nonverbal strategies than women, and in how they interpreted their partner's consent and nonconsent, with men relying more on nonverbal indicators of consent than women. Such gender differences may help to explain some misunderstandings or misinterpretations of consent or agreement to engage in sexual activity, which could partially contribute to the occurrence of acquaintance rape; thus, a better understanding of consent has important implications for developing sexual assault prevention initiatives.

Causes of childhood visual impairment and unmet low-vision care in blind school students in Ghana.

PubMed

Ntim-Amponsah, C T; Amoaku, W M K

2008-10-01

The purpose of this study was to determine the causes of childhood visual impairment and blindness in students of a school for blind children, to determine how many students had some residual vision, and to evaluate any unmet low-vision care. A survey of students in the blind school was conducted in two parts in May-June and then October 2003. The sample consisted of 201 students who became blind before the age of 16. Information was obtained from student interviews, doctors' referral notes and ophthalmic examination of all students who consented. Students with residual vision had low-vision assessments. These investigations were supplemented with active participation of the investigators in Parent-Teacher Association meetings and focus group discussions with parents. One hundred and ninety-nine students consented and were recruited, whereas two declined. Ninety-six became visually impaired within their first year of life and 33 by the age of 5 years. Pathology of the cornea and then the lens were the commonest causes of blindness. One hundred and eight students were totally blind, whereas 87 (43.7%) had some residual vision and formed the target for the second part of the study. Fifty-one out of 77 of this target group who turned up for low-vision examination had useful residual vision by the World Health Organisation (WHO) low-vision examination chart. Spectacle magnifiers aided two students to read normal print at N5 and N8, respectively. Different visual aids would help enhance the residual vision in some of the others. Emotional trauma was apparent in parents and teachers. Children who became blind later in life remained in shock for a longer time and adapted less well to their visual impairment. Visual impairment in the population is not uncommon. Some causes are preventable. There is a significant unmet need for low-vision care, particularly amongst children in Ghana, and perhaps many countries in the West Africa subregion. It is hoped that the findings from this study will help spur sustained interventions.

Permission Form Synopses to Improve Parents' Understanding of Research: A Randomized Trial

PubMed Central

D'Angio, Carl T.; Wang, Hongyue; Hunn, Julianne E.; Pryhuber, Gloria S.; Chess, Patricia R.; Lakshminrusimha, Satyan

2017-01-01

Objective We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). Study Design This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured. Result Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8 ± 5.7 v. 16.3 ± 3.5), subjective understanding (median 6.0 v. 6.5), or overall satisfaction with consent (median 7.0 v. 6.5) between control and intervention groups (all p>0.50). Conclusion A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited. PMID:28358380

Do parental involvement laws deter risky teen sex?

PubMed

Colman, Silvie; Dee, Thomas S; Joyce, Ted

2013-09-01

Parental involvement (PI) laws require that physicians notify or obtain consent from a parent(s) of a minor seeking an abortion before performing the procedure. Several studies suggest that PI laws curb risky sexual behavior because teens realize that they would be compelled to discuss a subsequent pregnancy with a parent. We show that prior evidence based on gonorrhea rates overlooked the frequent under-reporting of gonorrhea by race and ethnicity, and present new evidence on the effects of PI laws using more current data on the prevalence of gonorrhea and data that are novel to this literature (i.e., chlamydia rates and data disaggregated by year of age). We improve the credibility of our estimates over those in the existing literature using an event-study design in addition to standard difference-in-difference-in-differences (DDD) models. Our findings consistently suggest no association between PI laws and rates of sexually transmitted infections or measures of sexual behavior. Copyright © 2013 Elsevier B.V. All rights reserved.

Knowledge and attitude of Turkish parents regarding car safety seats for children.

PubMed

Sevketoğlu, Esra; Hatipoğlu, Sami; Esin, Gülbaran; Oztora, Serdar

2009-09-01

One of the major causes of death among children younger than 15 years is vehicular injury. Car safety seats protect children in a crash if they are used correctly. The objective of this study was to assess the level of parental knowledge and their attitudes regarding car safety seats. The survey was conducted in May and June 2007 at Bakirkoy Dr. Sadi Konuk Research-Training Hospital. Randomly selected parents were asked to complete an anonymous self-administered questionnaire after providing informed consent. Five hundred thirty-two Turkish parents were sampled. Twenty-eight percent of the parents did not know what a car safety seat was. While 20% of parents reported using a car safety seat, only 10% used them correctly. Car safety seat use was correlated with higher socioeconomic status. Increased education of parents regarding the proper use of child safety seats can protect children from potentially fatal injuries. Health care professionals are obligated to give information to parents regarding car safety seats and their proper use. This study should alert planners and policy makers regarding the need to implement educational prevention programs concerning car safety for children in Turkey.

Concussion Knowledge in High School Football Players

PubMed Central

Cournoyer, Janie; Tripp, Brady L.

2014-01-01

Context: Participating in sports while experiencing symptoms of a concussion can be dangerous. An athlete's lack of knowledge may be one factor influencing his or her decision to report symptoms. In an effort to enhance concussion education among high school athletes, legislation in Florida has attempted to address the issue through parental consent forms. Objective: To survey high school varsity football players to determine their level of knowledge about concussions after the initiation of new concussion-education legislation. Design: Cross-sectional study. Setting: Descriptive survey administered in person during a team meeting. Patients or Other Participants: A total of 334 varsity football players from 11 high schools in Florida. Main Outcome Measure(s): Participants completed a survey and identified the symptoms and consequences of a concussion among distractors. They also indicated whether they had received education about concussions from a parent, formal education, neither, or both. Results: The most correctly identified symptoms were headache (97%), dizziness (93%), and confusion (90%), and the most correctly identified consequence was persistent headache (93%). Participants reported receiving education from their parents (54%) or from a formal source (60%). Twenty-five percent reported never receiving any education regarding concussions. No correlations were found between the method of education and the knowledge of symptoms or consequences of concussion. Conclusions: The high school football players we surveyed did not have appropriate knowledge of the symptoms and consequences of concussions. Nausea or vomiting, neck pain, grogginess, difficulty concentrating, and personality or behavioral changes were often missed by participants, and only a small proportion correctly identified brain hemorrhage, coma, and death as possible consequences of inappropriate care after a concussion. Even with parents or guardians signing a consent form indicating they discussed concussion awareness with their child, 46% of athletes suggested they had not. PMID:25162779

Concussion knowledge in high school football players.

PubMed

Cournoyer, Janie; Tripp, Brady L

2014-01-01

Participating in sports while experiencing symptoms of a concussion can be dangerous. An athlete's lack of knowledge may be one factor influencing his or her decision to report symptoms. In an effort to enhance concussion education among high school athletes, legislation in Florida has attempted to address the issue through parental consent forms. To survey high school varsity football players to determine their level of knowledge about concussions after the initiation of new concussion-education legislation. Cross-sectional study. Descriptive survey administered in person during a team meeting. A total of 334 varsity football players from 11 high schools in Florida. Participants completed a survey and identified the symptoms and consequences of a concussion among distractors. They also indicated whether they had received education about concussions from a parent, formal education, neither, or both. The most correctly identified symptoms were headache (97%), dizziness (93%), and confusion (90%), and the most correctly identified consequence was persistent headache (93%). Participants reported receiving education from their parents (54%) or from a formal source (60%). Twenty-five percent reported never receiving any education regarding concussions. No correlations were found between the method of education and the knowledge of symptoms or consequences of concussion. The high school football players we surveyed did not have appropriate knowledge of the symptoms and consequences of concussions. Nausea or vomiting, neck pain, grogginess, difficulty concentrating, and personality or behavioral changes were often missed by participants, and only a small proportion correctly identified brain hemorrhage, coma, and death as possible consequences of inappropriate care after a concussion. Even with parents or guardians signing a consent form indicating they discussed concussion awareness with their child, 46% of athletes suggested they had not.

Recruitment of representative samples for low incidence cancer populations: Do registries deliver?

PubMed Central

2011-01-01

Background Recruiting large and representative samples of adolescent and young adult (AYA) cancer survivors is important for gaining accurate data regarding the prevalence of unmet needs in this population. This study aimed to describe recruitment rates for AYAs recruited through a cancer registry with particular focus on: active clinician consent protocols, reasons for clinicians not providing consent and the representativeness of the final sample. Methods Adolescents and young adults aged 14 to19 years inclusive and listed on the cancer registry from January 1 2002 to December 31 2007 were identified. An active clinician consent protocol was used whereby the registry sent a letter to AYAs primary treating clinicians requesting permission to contact the survivors. The registry then sent survivors who received their clinician's consent a letter seeking permission to forward their contact details to the research team. Consenting AYAs were sent a questionnaire which assessed their unmet needs. Results The overall consent rate for AYAs identified as eligible by the registry was 7.8%. Of the 411 potentially eligible survivors identified, just over half (n = 232, 56%) received their clinician's consent to be contacted. Of those 232 AYAs, 65% were unable to be contacted. Only 18 AYAs (7.8%) refused permission for their contact details to be passed on to the research team. Of the 64 young people who agreed to be contacted, 50% (n = 32) completed the questionnaire. Conclusions Cancer registries which employ active clinician consent protocols may not be appropriate for recruiting large, representative samples of AYAs diagnosed with cancer. Given that AYA cancer survivors are highly mobile, alternative methods such as treatment centre and clinic based recruitment may need to be considered. PMID:21235819

75 FR 7278 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-18

... the general requirements for informed consent to permit the use of investigational in vitro diagnostic... general requirements for informed consent, to permit the use of investigational in vitro diagnostic... exception to the general rule that informed consent is required for the use of an investigational in vitro...

"Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

ERIC Educational Resources Information Center

Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

2016-01-01

Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

78 FR 35040 - Submission for OMB Review; 30-day Comment Request; Web-Based Media Literacy Parent Training for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

...: Permission & Consent 200 1 10/60 33.33 Pretest 1 50/60 166.67 Posttest 1 45/60 150.00 Follow-up 1 45/60 150.00 Usage Log 2 10/60 67.00 Children: Assent 200 1 10/60 33.33 Pretest 1 50/60 166.67 Posttest 1 45/60...

Concerns regarding Direct-to-Consumer Hearing Aid Purchasing

ERIC Educational Resources Information Center

Kimball, Suzanne H.

2010-01-01

An individual over age 18 can purchase a hearing aid online or through mail order if they sign a waiver declining a medical evaluation, while those under 18 are required to be seen by a physician to obtain medical consent. However, in many states there is nothing to prevent a parent or caregiver from purchasing hearing aids for their child from a…

The Right to an Abortion--Problems with Parental and Spousal Consent

ERIC Educational Resources Information Center

Goldbach, Vicki

1976-01-01

Although the Supreme Court has held that the fourteenth amendment guarantee of privacy extends to the woman a qualified right to decide with her physician whether to terminate her pregnancy, it did not rule on how this right would extend to minors or the father of the fetus. Available from: 57-59 Worth Street, New York, N.Y. 10013. (LBH)

29 CFR 575.8 - Secretary's conditions for employment under the waiver.

Code of Federal Regulations, 2011 CFR

2011-07-01

... OF LABOR REGULATIONS WAIVER OF CHILD LABOR PROVISIONS FOR AGRICULTURAL EMPLOYMENT OF 10 AND 11 YEAR... person standing in the place of the parent of each 10 and 11-year old minor employed consenting to the... of employers shall employ any 10 or 11 year old minor pursuant to a waiver for more than 5 hours in...

A resolution concerning the suspension of exit permit issuance by the Government of the Democratic Republic of Congo for adopted Congolese children seeking to depart the country with their adoptive parents.

THOMAS, 113th Congress

Sen. Portman, Rob [R-OH

2014-07-15

Senate - 07/31/2014 Resolution agreed to in Senate with an amendment and an amended preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A qualitative study of participants' views on re-consent in a longitudinal biobank.

PubMed

Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

2017-03-23

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

Planned Parenthood of Southern Arizona v. Lawall.

PubMed

2002-01-01

Court Decision: 307 Federal Reporter, 3d Series 783; 2002 Oct 9 (date of decision). The U.S. Court of Appeals for the Ninth Circuit agreed with the lower court that Arizona's parental consent abortion law was constitutional because it adequately protected a minor's right to choose and privacy interests. Planned Parenthood brought an action contesting the constitutionality of Arizona's parental consent abortion law because it claimed the confidentiality provision did not comport with anonymity requirements upheld by the Supreme Court and a woman's informational privacy rights. The Ninth Circuit held that the confidentiality provision satisfied the required standard for anonymity because it took reasonable steps to prevent the public from learning the minor's identity. The court noted that complete anonymity was not required and, for this reason, the confidentiality provision did not unduly burden a woman's right to choose. The court also held that the law did not violate a woman's right of "informational" privacy (a privacy interest in avoiding disclosure of sensitive personal information) because the information was used in a manner that advanced a legitimate state interest, the law was sufficiently tailored to meet state interests, and the law provided adequate protection against unauthorized disclosure of personal information.

Protection of children's rights to self-determination in research.

PubMed

Sterling, Cheryl M; Walco, Gary A

2003-01-01

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.

"Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

PubMed

Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

2016-01-01

This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

The relationship between state abortion-restrictions and homicide deaths among children under 5 years of age: a longitudinal study.

PubMed

Sen, Bisakha; Wingate, Martha Slay; Kirby, Russell

2012-07-01

The purpose of this study is to explore whether, in the U.S., there are associations between state-level variations in mortality among young children and state abortion restriction policies - such as parental-consent requirements, parental-notification requirements, mandatory delay laws, and restrictions on Medicaid funding for abortion. To investigate this, we used NCHS Multiple Cause of Deaths public-use data files for the period 1983-2002, and compiled data on children ages 0-4 identified as having died as a result of assault/homicide in each state and year. Medicaid funding of abortion, mandatory delay laws, and parental involvement laws for minors seeking abortions were included as the main predictor variables of interest. Multivariate count data models using pooled state-year-age cohort data, with state and time fixed effects and other state-level controls, were estimated. Results indicated that, between 1983 and 2002, the average increase in the number of homicide deaths for children under 5 years of age was 5.70 per state among states that implemented stricter abortion policies over that time, and 2.00 per state for states that did not. In the count data models, parental-consent laws were associated with a 13 percent increase in child homicide deaths; parental-notification laws were associated with an 8 percent increase in child homicide deaths though the results were less robust to alternate model specifications; mandatory delay requirements were associated with a 13 percent increase in child homicide deaths. While these data do not allow us to discern precise pathways via which state abortion-restrictions can lead to more child homicide deaths, we speculate that state restrictions on abortion may result in a disproportionate increase in children born into relatively high-risk environments. Additional research is called for to explore the association of state abortion-restrictions with other measures of infant/child health and well-being. Copyright © 2012 Elsevier Ltd. All rights reserved.

Randomized pilot study to disseminate caries-control services in dentist offices

PubMed Central

Grembowski, David; Spiekerman, Charles; del Aguila, Michael A; Anderson, Maxwell; Reynolds, Debra; Ellersick, Allison; Foster, James; Choate, Leslie

2006-01-01

Background To determine whether education and financial incentives increased dentists' delivery of fluoride varnish and sealants to at risk children covered by capitation dental insurance in Washington state (U.S.). Methods In 1999, 53 dental offices in Washington Dental Service's capitation dental plan were invited to participate in the study, and consenting offices were randomized to intervention (n = 9) and control (n = 10) groups. Offices recruited 689 capitation children aged 6–14 and at risk for caries, who were followed for 2 years. Intervention offices received provider education and fee-for-service reimbursement for delivering fluoride varnish and sealants. Insurance records were used to calculate office service rates for fluoride, sealants, and restorations. Parents completed mail surveys after follow-up to measure their children's dental utilization, dental satisfaction, dental fear and oral health status. Regression models estimated differences in service rates between intervention and control offices, and compared survey measures between groups. Results Nineteen offices (34%) consented to participate in the study. Fluoride and sealant rates were greater in the intervention offices than the control offices, but the differences were not statistically significant. Restoration rates were lower in the intervention offices than the control offices. Parents in the intervention group reported their children had less dental fear than control group parents. Conclusion Due to low dentist participation the study lacked power to detect an intervention effect on dentists' delivery of caries-control services. The intervention may have reduced children's dental fear. PMID:16670027

[Under-age girl as a patient of pediatric and adolescent ginecology outpatient clinic].

PubMed

Sowińska-Przepiera, Elzbieta; Andrysiak-Mamos, Elzbieta; Syrenicz, Anhelli

2008-01-01

The research carried out in Poland reflected that sexual initiation before 18 years of age is a common phenomenon and refers to roughly 80% of teenagers. In Poland there is no uniform standing of medical and legal environments with regard to dealing with a juvenile patient who has become sexually active and expects the advice of a gynaecologist, gynaecologic examination and often asks for prescribing contraceptives. The procedures must take into account the fact that in Poland, until 18 years of age, a juvenile functions under the parental or tutelary authority, while a consent for medical service requires beside of the consent of legal guardian also the consent of a juvenile who is 16 years of age and becomes a full-right patient. According to the Act on Health Care Institutions, a patient has the right to self-decisions, the respect of physical and mental integrity and the respect of privacy, while the participation of a statutory representative post 16th year of age refers practically to co-deciding on a medical service provision. Therefore, the information received from such juvenile patient in subjective and objective examination does not have to be passed to the statutory representative, if the juvenile patient requires confidentiality and if this does not affect the patient's health and the planned medical procedures (e.g. the necessity of making an operation). The knowledge of conduct procedures with regard to a juvenile patient as a carrier of rights shall enable doctors to make aware choices of conduct and provide services or, in most cases, only advice, without the necessity to breach the laws of Poland.

Development and Psychometric Evaluation of the HPV Clinical Trial Survey for Parents (CTSP-HPV) Using Traditional Survey Development Methods and Community Engagement Principles.

PubMed

Cunningham, Jennifer; Wallston, Kenneth A; Wilkins, Consuelo H; Hull, Pamela C; Miller, Stephania T

2015-12-01

This study describes the development and psychometric evaluation of HPV Clinical Trial Survey for Parents with Children Aged 9 to 15 (CTSP-HPV) using traditional instrument development methods and community engagement principles. An expert panel and parental input informed survey content and parents recommended study design changes (e.g., flyer wording). A convenience sample of 256 parents completed the final survey measuring parental willingness to consent to HPV clinical trial (CT) participation and other factors hypothesized to influence willingness (e.g., HPV vaccine benefits). Cronbach's a, Spearman correlations, and multiple linear regression were used to estimate internal consistency, convergent and discriminant validity, and predictively validity, respectively. Internal reliability was confirmed for all scales (a ≥ 0.70.). Parental willingness was positively associated (p < 0.05) with trust in medical researchers, adolescent CT knowledge, HPV vaccine benefits, advantages of adolescent CTs (r range 0.33-0.42), supporting convergent validity. Moderate discriminant construct validity was also demonstrated. Regression results indicate reasonable predictive validity with the six scales accounting for 31% of the variance in parents' willingness. This instrument can inform interventions based on factors that influence parental willingness, which may lead to the eventual increase in trial participation. Further psychometric testing is warranted. © 2015 Wiley Periodicals, Inc.

Parental Virtue and Prenatal Genetic Alteration Research.

PubMed

Tonkens, Ryan

2015-12-01

Although the philosophical literature on the ethics of human prenatal genetic alteration (PGA) purports to inform us about how to act, it rarely explicitly recognizes the perspective of those who will be making the PGA decision in practice. Here I approach the ethics of PGA from a distinctly virtue-based perspective, taking seriously what it means to be a good parent making this decision for one's child. From this perspective, I generate a sound verdict on the moral standing of human PGA (research): given the current state of the art, good parents have compelling reason not to consent to PGA (research) for their child, especially as part of the first wave(s) of PGA research participants and especially for non-medically oriented purposes. This is because doing otherwise is inconsistent with a plausible and defensible understanding of virtuous parenting and parental virtues, founded on a genuine concern for promoting the overall flourishing of the eventual child. In essence, given the current and foreseeable state of the art, parents who allow prenatal genetic alteration of their children are less-than-virtuous parents to those children, even in cases where they have a right to do so and even if PGA turns out to be beneficial to the eventual child.

Parents of children with haemophilia at an early age: assessment of perceived stress and family functioning.

PubMed

Torres-Ortuño, A; Cuesta-Barriuso, R; Nieto-Munuera, J

2014-11-01

Haemophilia is a chronic disease that requires a multidisciplinary approach for proper management and control of its clinical manifestations. The perception and management of parents of children with haemophilia can be affected by stressful situations as a result of treatment or disease progression. The aim of this study was to evaluate the perception of stress and family functioning in parents of children with haemophilia 1-7 years. This is an observational clinical study involving 49 parents of children with haemophilia 1-7 years who attended the VIII Workshop for Parents of Children with haemophilia, organized by the Spanish Federation of Hemophilia in La Charca, Murcia (Spain). After obtaining parental consent, the questionnaires was applied to them, FACES III (family functioning) and Pediatric Inventory for Parents (perceived stress), and a record of data on the clinical characteristics and treatment. Significant differences in the perception of stressors by gender of parents were found. A family history of haemophilia, the use of port-a-cath, inhibitor development and gender of the parents were the descriptive variables most correlated with dependents variables. These variables, together with the type of haemophilia affect significantly in the parental stress and family functioning. Parents have difficulty adjusting to disease management, perceiving many stressors. Gender and family history, can hinder the proper compliance with treatments, reducing its effectiveness. © 2014 John Wiley & Sons Ltd.

Gillick, bone marrow and teenagers.

PubMed

Cherkassky, Lisa

2015-09-01

The Human Tissue Authority can authorise a bone marrow harvest on a child of any age if a person with parental responsibility consents to the procedure. Older children have the legal capacity to consent to medical procedures under Gillick, but it is unclear if Gillick can be applied to non-therapeutic medical procedures. The relevant donation guidelines state that the High Court shall be consulted in the event of a disagreement, but what is in the best interests of the teenage donor under s.1 of the Children Act 1989? There are no legal authorities on child bone marrow harvests in the United Kingdom. This article considers the best interests of the older saviour sibling and questions whether, for the purposes of welfare, the speculative benefits could outweigh the physical burdens. © The Author(s) 2015.

Minor Consent and Delivery of Adolescent Vaccines

PubMed Central

Ford, Carol A.; Skiles, Martha P.; English, Abigail; Cai, Jianwen; Agans, Robert P.; Stokley, Shannon; Markowitz, Lauri; Koumans, Emilia H.

2016-01-01

Purpose To explore whether, and to what extent, minor consent influences adolescent vaccine delivery in the United States. Methods A telephone survey was completed by 263 professionals with responsibilities for adolescent health care and/or vaccination in 43 states. Measures included perceived frequency of unaccompanied minor visits and perceived likelihood of vaccine delivery to unaccompanied minors in hypothetical scenarios that varied by adolescent age, vaccine type, visit type, and clinical setting. Results Among the 76 respondents most familiar with private primary care clinics, 47.1% reported perceptions that 17-year-old patients often present without a parent/legal guardian. Among the 104 respondents most familiar with public primary care clinics, 56.7% reported that 17-year-old patients often present alone. In response to hypothetical scenarios, approximately 30% of respondents familiar with private clinics and 50% of respondents familiar with public clinics reported perceptions that unaccompanied 17-year-old adolescents would not receive influenza, Tdap, or human papillomavirus vaccines during routine check-ups because they could not provide consent. Perceived likelihood of unaccompanied minors receiving vaccines when seen for confidential services in primary care, sexually transmitted disease, and Title X/family planning clinics varied significantly by vaccine type and clinical setting. On average, respondents reported that they would support minors having the ability to self-consent for vaccines at age 14. Conclusions The inability of minors to consent for vaccines is likely one barrier to vaccination. Interventions to increase adolescent vaccination should consider strategies that increase the ability of unaccompanied minors, particularly older minors, to receive vaccines within the context of legal, ethical, and professional guidelines. PMID:24074605

T.D. v. New York State Office of Mental Health.

PubMed

1995-02-28

The New York Supreme Court for New York County determined that a state regulation allowing substituted consent to research on mentally ill individuals by a spouse, parent, adult child or sibling, guardian, or authorized committee did not apply to nonfederally funded research. The court was asked by a group of involuntary state mental patients to decide on the validity of state regulations concerning participation in potentially high risk experimentation without consent. The patients, who were incapable of giving informed consent, claimed that their right to refuse treatment based on autonomy, privacy, due process, and equal protection was violated by provisions allowing substituted consent by third party decision makers. The court interpreted federal regulations on research and state regulations on public health and mental health as they applied to both federally funded and nonfederally funded, possibly therapeutic and nontherapeutic, research using non-FDA approved psychotropic drugs that could cause stroke, heart attack, convulsions, hallucinations, or death. The court found first, that the state mental health regulations covered the care, treatment, and rehabilitation of the mentally ill generally; second, that the state public health regulations specifically governed research on human subjects; and third, that the federal regulations controlled federally funded research unless state or local law provides additional protection. But in this case the state public health regulations did not apply to the federally funded research due to an exemption by the state legislature, but did apply to the nonfederally funded research, because not all the federal requirements had been met. The state mental health regulation on substituted consent was enacted without authority and thus was found to be invalid.

Comparing Web, Group and Telehealth Formats of a Military Parenting Program

DTIC Science & Technology

2017-06-01

directed approaches. Comparative effectiveness will be tested by specifying a non - equivalence hypothesis for group -based and web-facilitated relative...Comparative effectiveness will be tested by specifying a non - equivalence hypothesis fro group based and individualized facilitated relative to self-directed...documents for review and approval. 1a. Finalize human subjects protocol and consent documents for pilot group (N=5 families), and randomized controlled

A Journey of Self-Discovery: An Intervention Involving Massage, Yoga and Relaxation for Children with Emotional and Behavioural Difficulties Attending Primary Schools

ERIC Educational Resources Information Center

Powell, Lesley; Gilchrist, Mollie; Stapley, Jacqueline

2008-01-01

This study reports on an intervention involving massage, yoga and relaxation delivered to young children with emotional and behavioural difficulties. Children (n = 126) were invited to participate in the Self-discovery Programme (SDP) with parental consent. A total of 107 children aged 8-11 years completed the SDP and all measures. Children were…

A resolution congratulating the students, parents, teachers, and administrators of charter schools across the United States for ongoing contributions to education, and supporting the ideals and goals of the 12th annual National Charter Schools Week.

THOMAS, 112th Congress

Sen. Landrieu, Mary L. [D-LA

2011-05-02

Senate - 05/05/2011 Resolution agreed to in Senate without amendment and an amended preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Patients' acceptance of medical photography in a French adult and paediatric dermatology department: a questionnaire survey.

PubMed

Hacard, F; Maruani, A; Delaplace, M; Caille, A; Machet, L; Lorette, G; Samimi, M

2013-08-01

Despite the increasing use of medical photography by dermatologists, no study on patients' perceptions of photography in dermatology has been performed to date. Firstly, to evaluate patients' perceptions of medical photography. Secondly, to assess whether perceptions differed between patients in our adult department and parents accompanying a child in our paediatric department. An opinion survey was conducted at the Hospital of Tours (France) among adult patients (adult department) and accompanying parents (paediatric department) by completion of a questionnaire after any medical photography had been performed. We collected 272 questionnaires regarding 158 adults and 114 children. A camera used only in the department, and storage of the images in the department's records were the most accepted modalities (> 90%), especially in the paediatric survey. Respondents agreed with the sharing of the images with other practitioners and in medical meetings (> 85%) rather than distribution via publications (58·3%), e-mails (45·5%), health magazines (44·3%) and websites (32·0%). Most (78·8%) considered that the consent form should list all the possible uses of the images. Need for renewed consent for each use of the images was significantly more often expressed in the paediatric than the adult survey (44·5% vs. 24·5%, P = 0·001). More than 95% of respondents considered medical photography to be useful for improving diagnosis, monitoring of skin disease and aiding teaching. These findings could be used to improve practice, to increase the acceptability of medical photography and for devising a standardized consent form for medical practitioners performing medical photography. © 2013 The Authors BJD © 2013 British Association of Dermatologists.

Revisiting the best interest standard: uses and misuses.

PubMed

Diekema, Douglas S

2011-01-01

The best interest standard is the threshold most frequently employed by physicians and ethics consultants in challenging a parent's refusal to provide consent for a child's medical care. In this article, I will argue that the best interest standard has evolved to serve two different functions, and that these functions differ sufficiently that they require separate standards. While the best interest standard is appropriate for choosing among alternative treatment options for children, making recommendations to parents, and making decisions on behalf of a child when the legal decision makers are either unable to make a decision or are in dispute, a different standard is required for deciding when to seek state interference with parental decision-making authority. I will suggest that the harm principle provides a more appropriate threshold for determining when to seek state intervention than the best interest standard.

Parental consent requirements and privacy rights of minors: the contraceptive controversy.

PubMed

1975-03-01

That the adult zone of privacy recognized by the Supreme Court during the past decade embraces access to contraceptives is suggested. 2 further questions are examined: 1) whether the right of children to have access to contraceptives is fundamental and 2) whether countervailing interests of parents and state should outweigh whatever interest the child has in obtaining contraceptives. More fundamentally, 3 complex issues relative to an analysis of minors' rights to obtain contraceptives are discussed: 1) the scope of the constitutional right of adults to obtain contraceptives remains uncertain; 2) courts have not yet articulated the special factors that determine how existing frameworks for analyzing the rights of adults are to be applied to minors; and 3) the question of minors' access to contraceptive involves a particularly complex mixture of the interests of minors, parents, and the state.

The beliefs, motivations, and expectations of parents who have enrolled their children in a genetic biorepository.

PubMed

Harris, Erin D; Ziniel, Sonja I; Amatruda, Jonathan G; Clinton, Catherine M; Savage, Sarah K; Taylor, Patrick L; Huntington, Noelle L; Green, Robert C; Holm, Ingrid A

2012-03-01

Little is known about parental attitudes toward return of individual research results (IRRs) in pediatric genomic research. The aim of this study was to understand the views of the parents who enrolled their children in a genomic repository in which IRRs will be returned. We conducted focus groups with parents of children with developmental disorders enrolled in the Gene Partnership (GP), a genomic research repository that offers to return IRRs, to learn about their understanding of the GP, motivations for enrolling their children, and expectations regarding the return of IRRs. Parents hoped to receive IRRs that would help them better understand their children's condition(s). They understood that this outcome was unlikely, but hoped that their children's participation in the GP would contribute to scientific knowledge. Most parents wanted to receive all IRRs about their child, even for diseases that were severe and untreatable, citing reasons of personal utility. Parents preferred electronic delivery of the results and wanted to designate their preferences regarding what information they would receive. It is important for researchers to understand participant expectations in enrolling in a research repository that offers to disclose children's IRRs in order to effectively communicate the implications to parents during the consenting process.

Survey of Knowledge, Beliefs, and Behaviors of Migrant Vietnamese Parents Regarding Young Children's Oral Health.

PubMed

Nguyen, Uyen N; Rowe, Dorothy J; Barker, Judith C

2017-04-01

Purpose: The purpose of this study was to investigate the oral health knowledge, beliefs, and behaviors of migrant Vietnamese parents of 1-5 year-olds in San Jose, California. Method: A verbally-administered survey was conducted with a convenience sample of 45 Vietnamese parents recruited at San Jose public libraries. Following preliminary screening, written informed consent was obtained from eligible individuals. A pre-tested, structured 94-item questionnaire was used to collect information regarding parent demographics, and the parent's knowledge, beliefs, and behaviors about children's oral health. Simple descriptive statistics were used to analyze the data. Results: Vietnamese parents acknowledged a number of basic concepts regarding early childhood caries (ECC), such as influences of sugar consumption, oral hygiene, and bottle use. Unlike other groups, they reported some familiarity with the role of bacteria in caries etiology. Oral health knowledge and beliefs, however, were not reflected in parental oral health behaviors such as supervision of children's brushing. Knowledge about the preventive role of fluoride was limited and varied among the population. Parental knowledge and behaviors did not vary by education level or length of residence in US. Conclusion: Vietnamese parents demonstrated reasonably good oral health knowledge, but poor behavioral guidance of their children's oral health, indicating the need for continued parental education emphasizing age-appropriate oral care and the preventative role of fluoride. Copyright © 2017 The American Dental Hygienists’ Association.

Understanding sexuality among Indian urban school adolescents

PubMed Central

Ramadugu, Shashikumar; Ryali, VSSR; Srivastava, K.; Bhat, P. S.; Prakash, J.

2011-01-01

Context: Adolescence is a very exciting phase of life fraught with many challenges like sexuality. Understanding them is important in helping the adolescents grow up healthily. Aims: To ascertain the attitudes and knowledge about sexuality among school-going adolescents. Settings and Design: Students in two urban schools of an Indian city from class IX to XII were administered a self-reporting questionnaire on matters related to sexuality. Materials and Methods: Requisite ethical clearances were taken as also the consent of the parents and students before administration of the questionnaire. The authors clarified doubts to adolescents. Statistical analysis: Statistical package for social sciences. Results: The incidence of having sexual contact was 30.08% for boys and 17.18% for girls. 6.31% boys and 1.31% girls reported having had experienced sexual intercourse. Friends constituted the main sexual partners for both boys and girls. Sexual abuse had been reported by both girls and boys. These and other findings are discussed in the article. Conclusions: Adolescent school students are involved in sexual activity, but lack adequate knowledge in this regard. Students, teachers, and parents need to understand various aspects of sexuality to be able to help adolescents’ healthy sexual development. PMID:22969181

Awareness about and views of parents on the off-label drug use in children.

PubMed

Bang, V; Mallad, A; Kannan, S; Bavdekar, S B; Gogtay, N J; Thatte, U M

2014-01-01

Off-label use of drugs is widely prevalent in children mainly due to a limited data generated in children during drug development process. Parents play a critical role in giving consent for their child to participate in clinical trials. Very few studies have assessed the opinion of the parents regarding such use and permitting their child to participate in clinical trials. In view of lack of information about the awareness among parents regarding both off-label drug use in children as well as about allowing their child to participate in clinical research especially from a developing country, this study was conducted. Adults accompanying patients in a tertiary care hospital were administered a validated, structured questionnaire following written informed consent. The questionnaire consisted of 18 items broadly divided into 5 themes - parental views on safety and labelled use of drugs in children, awareness of off-label drug use in children, communication from healthcare worker about it, parental views on off-label drug use in children and willingness to allow their child to participate in a clinical trial. Chi-square or Fisher's exact probability test and McNemar's test were used for analysis. Initially, a majority of the participants felt that the drugs used in children in hospital (89.5%) and prescribed by a family physician (80.3%) were either safe or extremely safe while after the concept of off-label drug use is explained, a significant reduction in the proportion (59.3% in hospital and 59.8% by family physician) of parents felt the same. Only 30% parents were aware of off-label drug use in children. Ninety-three percent of the parents wanted to be informed whenever a doctor prescribes a drug in an off-label manner and a similar percentage felt the off-label drug use would increase the side-effects. Seventy three percent parents felt the off-label drug use is illegal and 57% would ask for change to a labelled drug in case of such prescription in their children. A majority of the parents would allow their child to participate in case of a life-threatening condition (59.8%) or in case of a chronic illness (51.3%) but significantly less when their child is healthy. The present study has found a low level of awareness regarding the concept of off-label drug use in children amongst the public. Our study also shows that parents expect that the doctor explains the fact to them, although they appear to vest a large amount of trust in the doctor's judgement in doing the best for their sick child. Parents were more willing to allow their child's participation in clinical research if their child was seriously ill than if healthy, indicating the need to educate the society about the need for clinical research so that they could take more informed decisions.

Adolescent and Parent Willingness to Participate in Microbicide Safety Studies

PubMed Central

Catallozzi, Marina; de Roche, Ariel M.; Hu, Mei-Chen; Breitkopf, Carmen Radecki; Chang, Jane; Ipp, Lisa S.; Francis, Jenny K. R.; Rosenthal, Susan L.

2018-01-01

Study Objective To understand adolescents’ and parents’ willingness to participate (WTP) in a hypothetical Phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making. Design Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes. Participants Adolescents (14–17 years old) and their parents (n=301 dyads) participated. Interventions None Main outcome measures Individual interviews at baseline assessed WTP on a six-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance. Results WTP was reported by 60% of adolescents and 52% of parents. In bivariate analyses, older adolescent age, sexual experience and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%) was more likely in dyads where the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%) and parents (88%) thought that the other would have similar views, influence their decision (adolescents 66%, parents 75%), and listen (adolescents 90%, parents 96%). There were no relationships between these perceptions and discordance. Conclusions Inclusion of adolescents in Phase 1 clinical trials is necessary to ensure that new methods are safe, effective and acceptable for them. Given that these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed. PMID:27381236

Managing ethically questionable parental requests: growth suppression and manipulation of puberty.

PubMed

Isaacs, David; Tobin, Bernadette; Hamblin, Julie; Slaytor, Emma; Donaghue, Kim C; Munns, Craig; Kilham, Henry A

2011-09-01

Doctors sometimes struggle with ethically challenging requests for treatment from children's parents. For instance, we have recently had two requests by parents of children, a girl and a boy, each with a severe developmental disability, for hormonal therapy to suppress growth and puberty: the girl's parents requested, in addition, hysterectomy and mastectomy. We propose a reliable approach to assessing the ethical and legal aspects of these and other requests for 'non-therapeutic' treatment of a minor who lacks the capacity to give informed consent. We argue that a doctor should first assess whether the request is one that he or she can, in conscience, accede to, and then, if it is, seek the authorisation of a court. We outline considerations relevant to the doctor's assessment of both the ethical issues and to the need for court authorisation. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Research Participation Decision-Making Among Youth and Parents of Youth With Chronic Health Conditions.

PubMed

Pagano-Therrien, Jesica; Sullivan-Bolyai, Susan

The aims of this qualitative descriptive study were to describe how past experiences with research (including communication, information, values, and support) may contribute to research fatigue among youth and parents of youth with HIV, cystic fibrosis, and Type 1 diabetes. Eighteen parents and youth were purposively recruited from outpatient subspecialty clinics at a major academic medical center. They took part in qualitative interviews and completed a demographics form and the Decisional Conflict Scale. Youth participants also completed the Erikson Psychosocial Stage Inventory. Two major themes emerged: Blurred Lines and Hope for the Future. Research fatigue was not found in this sample. Results point to challenges with informed consent in settings where research and clinical care are integrated and suggest that protective factors allow for continued participation without excess burden on youth and parents. Strategies to minimize research fatigue and support engagement in research are offered. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Pediatric interventional radiology clinic - how are we doing?

PubMed

Rubenstein, Jonathan; Zettel, Julie C; Lee, Eric; Cote, Michelle; Aziza, Albert; Connolly, Bairbre L

2016-07-01

Development of a pediatric interventional radiology clinic is a necessary component of providing a pediatric interventional radiology service. Patient satisfaction is important when providing efficient, high-quality care. To analyze the care provided by a pediatric interventional radiology clinic from the perspective of efficiency and parent satisfaction, so as to identify areas for improvement. The prospective study was both quantitative and qualitative. The quantitative component measured clinic efficiency (waiting times, duration of clinic visit, nurse/physician time allocation and assessments performed; n = 91). The qualitative component assessed parental satisfaction with their experience with the pediatric interventional radiology clinic, using a questionnaire (5-point Likert scale) and optional free text section for feedback (n = 80). Questions explored the family's perception of relevance of information provided, consent process and overall satisfaction with their pediatric interventional radiology clinic experience. Families waited a mean of 11 and 10 min to meet the physician and nurse, respectively. Nurses and physicians spent a mean of 28 and 21 min with the families, respectively. The average duration of the pediatric interventional radiology clinic consultation was 56 min. Of 80 survey participants, 83% were satisfied with their experience and 94% said they believed providing consent before the day of the procedure was helpful. Only 5% of respondents were not satisfied with the time-efficiency of the interventional radiology clinic. Results show the majority of patients/parents are very satisfied with the pediatric interventional radiology clinic visit. The efficiency of the pediatric interventional radiology clinic is satisfactory; however, adherence to stricter scheduling can be improved.

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

PubMed

Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

2018-03-01

No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

Parents Support Implementation of HIV Testing and Counseling at School: Cross-Sectional Study with Parents of Adolescent Attending High School in Gauteng and North West Provinces, South Africa

PubMed Central

Mokgatle, Mathildah

2016-01-01

Background. A formative assessment of the implementation of HIV testing and counseling (HTC) at school showed high acceptability and willingness to test among learners. However, the success of the proposed HTC depends on the support and acceptability of key stakeholders, including the parents. The aim of the study was to assess the opinions and acceptability of the implementation of HTC at school among parents of adolescents in high school. Methods. This was a cross-sectional household survey conducted with parents of adolescents attending high schools in educational districts in North West and Gauteng provinces, South Africa. Results. A total of 804 parents participated, and 548 (68.3%) were biological mothers, 85 (10.6%) were fathers, and the remaining were other relatives including grandmothers. Almost all (n = 742, 92.9%) parents were in support of implementation and provision of HTC at school, 701 (87.7%) would allow their children to be tested at school, 365 (46%) felt that parental consent was not needed to test at school, and 39.4% preferred to receive the HIV test results with their children. Conclusion. Parents accept the roll-out of an HTC program at school and have a role to play in supporting children who test positive for HIV. PMID:27807481

"Is It Like One of Those Infectious Kind of Things?" The Importance of Educating Young People about HPV and HPV Vaccination at School

ERIC Educational Resources Information Center

Davies, Cristyn; Skinner, Susan Rachel; Stoney, Tanya; Marshall, Helen Siobhan; Collins, Joanne; Jones, Jane; Hutton, Heidi; Parrella, Adriana; Cooper, Spring; McGeechan, Kevin; Zimet, Gregory

2017-01-01

The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for girls and in 2013 for boys, using the quadrivalent HPV [4vHPV] vaccine. In Australia, students are primarily vaccinated en masse, on school grounds, after parental/ guardian consent is obtained. Students most often receive little, or no, education at…

Consent Challenges for Participation of Young Men Who Have Sex With Men (YMSM) in HIV Prevention Research in Thailand

PubMed Central

Guadamuz, Thomas E.; Goldsamt, Lloyd A.; Boonmongkon, Pimpawun

2014-01-01

Young men who have sex with men (YMSM) under 18 years are often excluded from HIV prevention research in Thailand due to cultural attitudes toward youth sexuality, social stigma, and difficulties obtaining guardian permission. Culturally sensitive focus group discussions conducted with parents and YMSM in Bangkok, Thailand identified barriers and facilitators related to minors’ participation in HIV prevention research. Although gender and class differences emerged, mothers and fathers were generally accepting of research to reduce HIV risk, but not in favor of waiver. Youth’s positive attitude toward parental permission was tempered by concerns about harms posed by disclosing same-sex attraction through permission forms. PMID:25750498

Consent Challenges for Participation of Young Men Who Have Sex With Men (YMSM) in HIV Prevention Research in Thailand.

PubMed

Guadamuz, Thomas E; Goldsamt, Lloyd A; Boonmongkon, Pimpawun

2015-03-01

Young men who have sex with men (YMSM) under 18 years are often excluded from HIV prevention research in Thailand due to cultural attitudes toward youth sexuality, social stigma, and difficulties obtaining guardian permission. Culturally sensitive focus group discussions conducted with parents and YMSM in Bangkok, Thailand identified barriers and facilitators related to minors' participation in HIV prevention research. Although gender and class differences emerged, mothers and fathers were generally accepting of research to reduce HIV risk, but not in favor of waiver. Youth's positive attitude toward parental permission was tempered by concerns about harms posed by disclosing same-sex attraction through permission forms.

Elementary School-Based Influenza Vaccination: Evaluating Impact on Respiratory Illness Absenteeism and Laboratory-Confirmed Influenza

PubMed Central

Kjos, Sonia A.; Irving, Stephanie A.; Meece, Jennifer K.; Belongia, Edward A.

2013-01-01

Background Studies of influenza vaccine effectiveness in schools have assessed all-cause absenteeism rather than laboratory-confirmed influenza. We conducted an observational pilot study to identify absences due to respiratory illness and laboratory-confirmed influenza in schools with and without school-based vaccination. Methods A local public health agency initiated school-based influenza vaccination in two Wisconsin elementary schools during October 2010 (exposed schools); two nearby schools served as a comparison group (non-exposed schools). Absences due to fever or cough illness were monitored for 12 weeks. During the 4 weeks of peak influenza activity, parents of absent children with fever/cough illness were contacted and offered influenza testing. Results Parental consent for sharing absenteeism data was obtained for 937 (57%) of 1,640 students. Fifty-two percent and 28%, respectively, of all students in exposed and non-exposed schools were vaccinated. Absences due to fever or cough illness were significantly lower in the exposed schools during seven of 12 surveillance weeks. Twenty-seven percent of students at exposed schools and 39% at unexposed schools had one or more days of absence due to fever/cough illness (p<0.0001). There was no significant difference in the proportion of students absent for other reasons (p = 0.23). During the 4 week period of influenza testing, respiratory samples were obtained for 68 (42%) of 163 episodes of absence due to fever or cough illness. Influenza was detected in 6 students; 3 attended exposed schools. Conclusions Detection of laboratory-confirmed influenza in schools was challenging due to multiple consent requirements, difficulty obtaining samples from absent children, and a mild influenza season. School-based influenza vaccination was associated with reduced absenteeism due to fever or cough illness, but not absenteeism for other reasons. Although nonspecific, absence due to fever or cough illness may be a useful surrogate endpoint in school-based studies if identification of laboratory confirmed influenza is not feasible. PMID:23991071

Quality of life in pediatric cancer survivors: contributions of parental distress and psychosocial family risk.

PubMed

Racine, N M; Khu, M; Reynolds, K; Guilcher, G M T; Schulte, F S M

2018-02-01

Pediatric survivors of childhood cancer are at increased risk of poor quality of life and social-emotional outcomes following treatment. The relationship between parent psychological distress and child adjustment in pediatric cancer survivors has been well established. However, limited research has examined the factors that may buffer this association. The current study examined the associations between psychosocial family risk factors, parental psychological distress, and health-related quality of life (hrql) in pediatric cancer survivors. Fifty-two pediatric cancer survivors (34 males, 18 females, mean age = 11.92) and their parents were recruited from a long-term cancer survivor clinic. Children and their parents who consented to participate completed the Pediatric Quality of Life Inventory 4.0. Parents completed a demographic information form, the Psychosocial Assessment Tool (pat 2.0) and the Brief Symptom Inventory (bsi). The Intensity of Treatment Rating (itr-3) was evaluated by the research team. Multiple regression analyses revealed that parental psychological distress negatively predicted parent-reported hrql, while treatment intensity, gender, and psychosocial risk negatively predicted parent and child-reported hrql. Psychosocial risk moderated the association between parent psychological distress and parent-reported child hrql ( p = 0.03), whereby parents with high psychological distress but low levels of psychosocial risk reported their children to have higher hrql. Low levels of family psychosocial risk buffer the impact of parent psychological distress on child hrql in pediatric cancer survivors. The findings highlight the importance of identifying parents and families with at-risk psychological distress and psychosocial risk in order to provide targeted support interventions to mitigate the impact on hrql.

[Data protection. Barrier or helpful orientation for cooperation in early intervention?].

PubMed

Schönecker, L; Meysen, T

2010-11-01

From birth until the age of 3 years, the health care system is the central help system and point of contact for parents with their children. Professionals in health care are given considerable trust. However, many of the essential services, especially for families with increased needs, can only be found in the child welfare system. The authors describe a plan for a lawful and functionally adequate transition between the two systems that eases access to additional help. Functional data protection secures a relationship of trust between the doctor and patient. It requires the promotion of a consensual transition. If the transmission of information is necessary, not without the knowledge but without the consent of the parents, the law permits the transfer of information under certain conditions. For doctors, midwifes, pediatric nurses, and other health professionals, this results in a legal examination program with respect to the supporting relationship to their patient. On the one hand, it contains an assessment of the child's endangerment and, on the other hand, an estimation of the sustainability of the assistance they entered into for the prevention of further harm or the solicitation of voluntary utilization of additional help. The article introduces the different new federal state laws on data transfer without consent in cases of potential child endangerment.

[Dental and health law 4. The treatment of minors and of adults who are unable to give informed consent].

PubMed

Brands, W G; van der Ven, J M; Brands-Bottema, G W

2013-01-01

When minors are treated, a complex triangular relationship can emerge among dentist, patient and the individual legally responsible for the patient. Generally speaking, both parents are those legally responsible for a child. This might not be the case if the parents are not married to each other or have divorced, or when there is a question of a child protection ruling. The governing rule is that dentists are required to honour the obligations to the legal representatives thatfollow from the patients' rights concerning the treatment of children under the age of 12. In the case of patients between the ages of 12 and 16, dentists are required to act in accordance with their obligations to both those legally responsible and to the patients. Finally, in the case ofpatients who are 16 and older, dentists are required to act only in accordance with their obligations to the patients. There are, however, various exceptions to this governing rule. One of the most common examples is the patient who is a minor of 16 or older who is unable to determine what is in his own best interest. That criterium is also used in determining the capability to give informed consent in adults.

Planned Parenthood League of Massachusetts v. Bellotti.

PubMed

1989-02-07

The Planned Parenthood League of Massachusetts instituted a class action suit challenging the constitutionality of a statute requiring minors seeking an abortion to obtain parental consent or to persuade a judge of their maturity to give informed consent or that abortion would be in their best interest. In order to invoke judicial review, the plaintiffs moved their suit to federal court. The District Court dismissed the case on grounds that federal review power would interfere with state administration. On appeal, the First Circuit Court of Appeals decided that the plaintiffs could proceed with their action. The Circuit Court found that federal adjudication would not unduly interfere with state administration and remanded the case for further proceedings. Although it affirmed the statute's validity, the circuit court ruled that the plaintiffs must be allowed the opportunity to demonstrate the statute's unconstitutionality.

Norwood Hospital v. Munoz.

PubMed

1991-01-15

Norwood Hospital petitioned the Probate and Family Court of Norfolk County, Masssachusetts, for an order authorizing it to administer blood to Munoz, a Jehovah's Witness and mother of a minor child, without her consent. On appeal, the Supreme Judicial Court of Massachusetts held that Munoz had a constitutional and common law right to refuse a blood transfusion. The doctrine of informed consent requires a doctor to disclose to competent patients information sufficient to enable them to make an informed judgment on whether to receive medical treatment. While this right can be outweighed by certain interests, including protection of innocent third parties, that interest only outweighs the parent's choice where there is compelling evidence that the child will be abandoned. The record here revealed strong family support for Munoz' decision, and the family's willingness and means to care for the child.

Teens and Research.

PubMed

Neuhaus, Carolyn Plunkett

2016-10-01

On seeing promising results in a small number of patients, some researchers are conducting trials to determine whether deep brain stimulation (DBS) is an effective treatment for anorexia nervosa (AN). This article asks whether we should open enrollment in trials of DBS for AN to adolescents. Despite concerns about informed consent, parental consent, and unforeseeable psychological sequelae, the article concludes that the risks to anorexic adolescents associated with participation in trials of DBS are reasonable considering the substantial risks of not enrolling teens with AN in research on DBS. The seriousness of AN, its high incidence in teens, and serious shortfalls in the AN treatment literature point to the need for improved, evidence-based treatments for teens with AN. This unmet need generates an obligation on the part of researchers and physicians to promote and conduct research on AN in adolescents.

Using Facebook to Recruit Parents to Participate in a Family Program to Prevent Teen Drug Use.

PubMed

Oesterle, Sabrina; Epstein, Marina; Haggerty, Kevin P; Moreno, Megan A

2018-05-01

Despite strong evidence that family programs are effective in preventing adolescent substance use, recruiting parents to participate in such programs remains a persistent challenge. This study explored the feasibility of using Facebook to recruit parents of middle school students to a self-directed family program to prevent adolescent drug use. The study used paid Facebook ads aiming to recruit 100 parents in Washington and Colorado using marijuana- or parenting-focused messages. All ad-recruited parents were also invited to refer others in order to compare Facebook recruitment to web-based respondent-driven sampling. Despite offering a $15 incentive for each successfully referred participant, the majority of the screened (70.4%) and eligible (65.1%) parents were recruited through Facebook ads. Yet, eligibility and consent rates were significantly higher among referred (76.6 and 57.3%, respectively) than Facebook-recruited parents (60.0 and 36.6%, respectively). Click-through rates on Facebook were higher for marijuana-focused than parenting-focused ads (0.72 and 0.65%, respectively). The final sample (54% Facebook-recruited) consisted of 103 demographically homogeneous parents (female, educated, non-Hispanic White, and mostly from Washington). Although Facebook was an effective and efficient method to recruit parents to a study with equal to better cost-effectiveness than traditional recruitment strategies, the promise of social media to reach a diverse population was not realized. Additional approaches to Facebook recruitment are needed to reach diverse samples in real-world settings and increase public health impact of family programs.

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya.

PubMed

Okello, George; Jones, Caroline; Bonareri, Maureen; Ndegwa, Sarah N; McHaro, Carlos; Kengo, Juddy; Kinyua, Kevin; Dubeck, Margaret M; Halliday, Katherine E; Jukes, Matthew C H; Molyneux, Sassy; Brooker, Simon J

2013-05-16

There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. National Institute of Health NCT00878007.

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya

PubMed Central

2013-01-01

Background There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Methods Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors’ experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Results Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. Conclusions A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. Trial registration National Institute of Health NCT00878007 PMID:23680181

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation

PubMed Central

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Objective To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. Setting We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants’ comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. Participants The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. Outcome measure The primary outcome measure was reliability and validity of the questionnaire. Results Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73–0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. Conclusions We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. PMID:24961716

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

PubMed

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-06-24

To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. The primary outcome measure was reliability and validity of the questionnaire. Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Community-based parent-delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low-resource country (Learning through Everyday Activities with Parents (LEAP-CP): protocol for a randomised controlled trial.

PubMed

Benfer, Katherine A; Novak, Iona; Morgan, Catherine; Whittingham, Koa; Khan, Naila Zaman; Ware, Robert S; Bell, Kristie L; Bandaranayake, Sasaka; Salt, Alison; Ghosh, Asis Kumar; Bhattacharya, Anjan; Samanta, Sandip; Moula, Golam; Bose, Dilip; Tripathi, Santanu; Boyd, Roslyn N

2018-06-22

Cerebral palsy (CP) is the most common childhood physical disability, with 80% estimated to be in low-middle-income countries. This study aims to (1) determine the accuracy of General Movements (GMs)/Hammersmith Infant Neurological Examination (HINE) for detecting CP at 18 months corrected age (CA); (2) determine the effectiveness of a community-based parent-delivered early intervention for infants at high risk of CP in West Bengal, India (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). This study comprises two substudies: (1) a study of the predictive validity of the GMs and HINE for detecting CP; (2) randomised, double-blinded controlled trial of a novel intervention delivered through peer trainers (Community Disability Workers, CDW) compared with health advice (15 fortnightly visits). 142 infants at high risk of CP ('absent fidgety' GMs; 'high risk score' on HINE) aged 12-40 weeks CA will be recruited to the intervention substudy, with infants randomised based on a computer-generated sequence. Researchers will be masked to group allocation, and caregivers and CDWs naïve to intervention status. Visits will include therapeutic modules (goal-directed active motor/cognitive strategies and LEAP-CP games) and parent education. Health advice is based on the Integrated Management of Childhood Illness, WHO. Infants will be evaluated at baseline, post intervention and 18 months CA. The primary hypothesis is that infants receiving LEAP-CP will have greater scaled scores on the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (mobility domain) at 18 months compared with health advice. Secondary outcomes include infant functional motor, cognitive, visual and communication development; infant growth; maternal mental health. This study is approved through appropriate Australian and Indian ethics committees (see in text) with families providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations. 12616000653460p; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Law & Order, CSI, and NCIS: The Association Between Exposure to Crime Drama Franchises, Rape Myth Acceptance, and Sexual Consent Negotiation Among College Students.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Lei, Ming; Ren, Chunbo; Ran, Weina

2015-01-01

Previous research has identified that exposure to the crime drama genre lowers rape myth acceptance and increases sexual assault prevention behaviors such as bystander intervention. However, recent content analyses have revealed marked differences in the portrayal of sexual violence within the top three crime drama franchises. Using a survey of 313 college freshmen, this study explores the influence of exposure to the three most popular crime drama franchises: Law & Order, CSI, and NCIS. Findings indicate that exposure to the Law & Order franchise is associated with decreased rape myth acceptance and increased intentions to adhere to expressions of sexual consent and refuse unwanted sexual activity; whereas exposure to the CSI franchise is associated with decreased intentions to seek consent and decreased intentions to adhere to expressions of sexual consent. Exposure to the NCIS franchise was associated with decreased intentions to refuse unwanted sexual activity. These results indicate that exposure to the specific content of each crime drama franchise may have differential results on sexual consent negotiation behaviors.

Boldt v. Boldt: A pediatric ethics perspective.

PubMed

Diekema, Douglas S

2009-01-01

On balance, the potential harms and benefits of circumcision in an older child or adolescent are sufficiently closely aligned that parents should be permitted to make decisions about circumcision on behalf of their children. To make a case for prohibition, medical harms would have to be of such likelihood and magnitude that no reasonable potential benefit (social, religious, cultural, or medical) could justify doing it to a child. However, I would suggest that the following additional principles should apply: (1) Informed permission from parents is essential. Only about half of the parents considering neonatal circumcision are given any substantive information about the procedure. That practice is not acceptable for a procedure that is not medically essential and carries some risk of harm. A fully informed consent is essential, and must include a balanced discussion of potential harms and benefits of the procedure to the child. Parents should be given accurate and impartial information and allowed to make an informed decision regarding what is in the best interest of the child. (2) Consent of both parents should be required when the procedure is not medically required. It should not be performed in the face of parental disagreement. (3) Absent a significant medical indication, circumcision should not be performed on older children and adolescents in the face of dissent or less than enthusiastic assent. (4) Circumcision should be performed competently and safely by adequately trained providers.29 This should include infection-control measures, a sterile environment for the procedure, and no mouth-penis contact. (5) Analgesia is safe and effective. Adequate analgesia and post-operative pain control must be provided. In the case of Jimmy Boldt, I would suggest that without some compelling medical reason for performing a circumcision, the procedure should not be performed in the absence of agreement between his parents. The fact that Jimmy's father had sole custody does not eliminate the mother's ethical right and obligation to look after the welfare of her son. While the mother may not have legal decision-making authority, that legal determination does not appear to be related either to a lack of interest in her son's welfare or an inability to carry out that role. Jimmy is her son, and she has an interest in seeing his welfare protected. Whether or not she has legal rights, I would be very reluctant to perform an elective procedure for cultural or religious reasons without the permission of both parents and the unambiguous assent of Jimmy himself. Neither appears to be present in the case as it presented to the courts.

Improving early relationships: a randomized, controlled trial of an age-paced parenting newsletter.

PubMed

Waterston, Tony; Welsh, Brenda; Keane, Brigid; Cook, Margaret; Hammal, Donna; Parker, Louise; McConachie, Helen

2009-01-01

Parenting is recognized as a key mediator in both health and educational outcomes. Much is known on the value of support and group work in benefiting parenting, but little is known on the effect of written information. A randomized, controlled trial was conducted to evaluate the effect of a parenting newsletter, sent monthly to the parents' home from birth to 1 year, on maternal well-being and parenting style. We tested the hypothesis that mothers receiving the newsletter would show less stress and better parenting characteristics than controls. Parents of first infants born in a North East England District General Hospital between February and October 2003 who consented to take part in the study were randomly allocated to either the intervention or control arm. Those in the intervention arm were sent 12 monthly issues of an age-paced parenting newsletter containing information on emotional development, parent-child interaction, and play. Both the intervention and control group received normal parenting support. Mothers in both groups completed the Well-being Index, Parenting Daily Hassles Scale, and the Adult-Adolescent Parenting Inventory at birth and at 1 year. One hundred eighty-five mothers were recruited, with 94 randomly assigned to the intervention group, and 91 controls. Allowing for differences at recruitment, there were significant differences between the groups at 1 year: the intervention mothers had lower frequency and intensity of perceived hassles and fewer inappropriate expectations of the infant on the Adult-Adolescent Parenting Inventory than the control mothers. A monthly parenting newsletter sent directly to the home in the first year of life seems to help parents to understand their infant better and feel less hassled. This intervention is low cost and can be applied to all parents, so it is nonstigmatizing.

The role of consent in medical research: breaking or building walls? A call for legislative reform.

PubMed

Dangata, Yohanna Yanshiyi

2011-12-01

Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study.

PubMed

McConnell, Michael V; Shcherbina, Anna; Pavlovic, Aleksandra; Homburger, Julian R; Goldfeder, Rachel L; Waggot, Daryl; Cho, Mildred K; Rosenberger, Mary E; Haskell, William L; Myers, Jonathan; Champagne, Mary Ann; Mignot, Emmanuel; Landray, Martin; Tarassenko, Lionel; Harrington, Robert A; Yeung, Alan C; Ashley, Euan A

2017-01-01

Studies have established the importance of physical activity and fitness, yet limited data exist on the associations between objective, real-world physical activity patterns, fitness, sleep, and cardiovascular health. To assess the feasibility of obtaining measures of physical activity, fitness, and sleep from smartphones and to gain insights into activity patterns associated with life satisfaction and self-reported disease. The MyHeart Counts smartphone app was made available in March 2015, and prospective participants downloaded the free app between March and October 2015. In this smartphone-based study of cardiovascular health, participants recorded physical activity, filled out health questionnaires, and completed a 6-minute walk test. The app was available to download within the United States. The feasibility of consent and data collection entirely on a smartphone, the use of machine learning to cluster participants, and the associations between activity patterns, life satisfaction, and self-reported disease. From the launch to the time of the data freeze for this study (March to October 2015), the number of individuals (self-selected) who consented to participate was 48 968, representing all 50 states and the District of Columbia. Their median age was 36 years (interquartile range, 27-50 years), and 82.2% (30 338 male, 6556 female, 10 other, and 3115 unknown) were male. In total, 40 017 (81.7% of those who consented) uploaded data. Among those who consented, 20 345 individuals (41.5%) completed 4 of the 7 days of motion data collection, and 4552 individuals (9.3%) completed all 7 days. Among those who consented, 40 017 (81.7%) filled out some portion of the questionnaires, and 4990 (10.2%) completed the 6-minute walk test, made available only at the end of 7 days. The Heart Age Questionnaire, also available after 7 days, required entering lipid values and age 40 to 79 years (among 17 245 individuals, 43.1% of participants). Consequently, 1334 (2.7%) of those who consented completed all fields needed to compute heart age and a 10-year risk score. Physical activity was detected for a mean (SD) of 14.5% (8.0%) of individuals' total recorded time. Physical activity patterns were identified by cluster analysis. A pattern of lower overall activity but more frequent transitions between active and inactive states was associated with equivalent self-reported cardiovascular disease as a pattern of higher overall activity with fewer transitions. Individuals' perception of their activity and risk bore little relation to sensor-estimated activity or calculated cardiovascular risk. A smartphone-based study of cardiovascular health is feasible, and improvements in participant diversity and engagement will maximize yield from consented participants. Large-scale, real-world assessment of physical activity, fitness, and sleep using mobile devices may be a useful addition to future population health studies.

Finland on a road towards a modern legal biobanking infrastructure.

PubMed

Soini, Sirpa

2013-06-01

Finland has enacted a Biobank Act that will come into force on 1 September 2013. Finland is regarded as a highly successful environment for medical research using population samples and data for many reasons. One of the rationales behind the new legislation was to solve the problems due to the overly strict informed consent doctrine hindering access to old samples and data and asking for multi-purpose consents. Yet although consent is the primary justification to use biobank samples and data, the Biobank Act allows asking for a consent for several unspecified future research purposes. The guiding principles of the Biobank Act are promotion of trust, equal access to data and samples, protection of privacy, acceleration of innovation activities, and bringing biobank activities under public scrutiny. To the author's knowledge, this is the first "all purpose" Biobank Act in Europe applied to all biobanks in one country.

Therapeutic cloning and reproductive liberty.

PubMed

Sparrow, Robert

2009-04-01

Concern for "reproductive liberty" suggests that decisions about embryos should normally be made by the persons who would be the genetic parents of the child that would be brought into existence if the embryo were brought to term. Therapeutic cloning would involve creating and destroying an embryo, which, if brought to term, would be the offspring of the genetic parents of the person undergoing therapy. I argue that central arguments in debates about parenthood and genetics therefore suggest that therapeutic cloning would be prima facie unethical unless it occurred with the consent of the parents of the person being cloned. Alternatively, if therapeutic cloning is thought to be legitimate, this undermines the case for some uses of reproductive cloning by implying that the genetic relation it establishes between clones and DNA donors does not carry the same moral weight as it does in cases of normal reproduction.

Pediatric Issues in Return of Results and Incidental Findings: Weighing Autonomy and Best Interests.

PubMed

Holm, Ingrid A

2017-03-01

Nowhere are the ethical issues in genomic research more complex than in pediatrics. Balancing the sometime conflicting autonomy of the parent and the child, and the best interest of the family and the child, brings up many challenging issues. Addressing this balance, especially in the context of the child's developing maturity and comprehension, requires deep analysis and discussion. Issues discussed include the impact of genetic information on the family, parental versus the child's autonomy, the best interests of the child versus the family, potential limitations on the parents' right to know or not know information about their child, and changing role of the developing child in return of research results. Finally, a dynamic model will be proposed that takes into consideration the child's evolving role in consenting and return of results that can be adapted in different national contexts.

Legal regulation of surrogate motherhood in Israel.

PubMed

Frenkel, D A

2001-01-01

The Israeli Law on surrogate motherhood demands a preconception agreement to include payments to be made to the surrogate mother. Surrogacy arrangements with family members are forbidden. Commercial surrogacy is allowed and encouraged. The Law causes many problems. Validity of consent given by surrogate mothers is doubtful. Possible future psychological harm are ignored. There is a danger of "commodification" of children. Abusing women of low socio-economic status as breeding machines may be another outcome. No clear responsibility is imposed on the "intended parents" for an impaired child. The law ignores possibility of divorce or death of the "intended parents" before the child's birth. Splitting motherhood is another social problem that has to be dealt with. So far the sperm of the husband from the "intended parents" has to be used, but further steps may follow. It is not certain that a policy of "positive eugenics" will not develop.

Parental dreams, dilemmas, and decision-making in cinéma vérité.

PubMed

Little, G A; Kahn, R; Green, R M

1999-01-01

Our film Dreams and Dilemmas: Parents and the Practice of Neonatal Care is on its way to meeting its goal of furthering the "Principles for Family Centered Neonatal Care" (Harrison H. Pediatrics 1993;92:643-50) through cinéma vérité depiction of parental involvement in decision-making. Reality-based filmmaking can provide valuable and successful educational material that advances care and understanding. However, there are real practical and ethical concerns such as privacy, consent, and uncertain or unknown future impact on participants. Successful reality-based filmmaking in a complex medical environment such as a neonatal intensive care unit requires careful attention to ways of ensuring full communication between all those involved and efforts to allay participants' anxiety about being portrayed unfavorably. The most important ingredient, however, is the skill and ability of the filmmaker to engender trust.

Perceived legitimacy of parental authority and tobacco and alcohol use during early adolescence.

PubMed

Jackson, Christine

2002-11-01

To assess the likelihood that young adolescents perceive that parents have legitimate authority regarding cigarette smoking and alcohol consumption; to test whether perceived parental authority predicts adolescents' use of tobacco and alcohol, and to test the association between parenting style and the legitimacy of parental authority regarding tobacco and alcohol. Survey data were obtained in 1997 from 1220 sixth and eighth grade adolescents enrolled in a central North Carolina school district. The sample comprised 72.3% of 1687 eligible students and 92.3% of 1321 students with parental consent; 83.8% of the sample was European-American and 16.2% African-American. Students completed self-report questionnaires administered in classrooms. Logistic regression models were used to test the study hypotheses. Adolescents were significantly more likely to legitimize parental authority regarding tobacco and alcohol than parental authority regarding conventional or contemporary issues. Failure to legitimize parental authority was associated with significantly greater odds of current smoking (OR = 4.06; p <.000) or drinking (OR = 3.81; p <.000) among all respondents, and significantly greater odds of intending to smoke (OR = 3.38; p <.000) or drink (OR = 3.38; p <.000) among abstinent respondents. Adolescents' perceptions of parental authority regarding tobacco and alcohol varied significantly by parenting style. The results discredit the myth that adolescents uniformly disregard parental values and rules regarding tobacco and alcohol. The results also showed that general parenting style covaried strongly with adolescents' perceptions of parental authority regarding substance use. Additional research is warranted to test for causal relations between general parenting style, adolescents' perceptions of parental authority regarding substance use, and adolescents' risk of substance use.

[Issues related to consent to healthcare decisions in children and adolescents].

PubMed

Bailly, D

2010-02-01

The process of consent to healthcare decisions in children and adolescents often set physicians difficult problems. From what age is a child able to understand the information given to him or her about illness and treatment? Is an ill child indeed in the capacity to give his or her voluntary consent to treatment? How to define and to assess the capacity of an ill child to take part in treatment decisions? More than the age of the child, it is his or her level of cognitive, emotional and social development and its interactions with illness that will determine his or her degree of involvement in the decision-making process. There is a moral and ethical need to respect the rights and autonomy of every individual, regardless of age. This does not mean viewing children and adolescents as rational and autonomous decision-makers. This implies that we must promote their developmentally appropriate participation in shared decision-making with parents and physicians. Therefore, instead of asking, "should children and adolescents be granted absolute autonomy in decision making?" we ought to ask, "should we treat children and adolescents like people?" Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

Prevalence and risk factors for myopia in second-grade primary school children in Taipei: A population-based study.

PubMed

Hsu, Chih-Chien; Huang, Nicole; Lin, Pei-Yu; Tsai, Der-Chong; Tsai, Ching-Yao; Woung, Lin-Chung; Liu, Catherine Jui-Ling

2016-11-01

High myopia is associated with multiple ocular morbidities that may lead to irreversible blindness. Because high myopia in an adult is thought to be related to onset of myopia in very early childhood, detecting myopia early and working to improve modifiable risk factors may help reduce the development of high myopia. In this study, we tried to evaluate the prevalence of myopia and associated risk factors in second-grade primary school children in Taipei, Taiwan. A questionnaire was distributed to the participants' parents, and their written informed consent was obtained before performing eye examinations that included visual acuity testing and cycloplegic autorefraction. Multiple logistic regression models were applied to assess possible risk factors associated with myopia. Myopia was defined as spherical equivalent of -0.50 D or less in either eye. The prevalence of myopia in the second graders was 36.4%. After adjustment for other characteristics, the following variables were significantly associated with a higher risk of myopia: male sex [odds ratio (OR)=1.24, p<0.001]; suburban residence (vs. urban; OR=1.10, p=0.02); lower maternal education level (OR=1.25, p<0.001); the presence of myopia in one parent (OR=1.66, p<0.001) or both parents (OR=2.82, p<0.001); time spent on near-work activity every day (OR=1.21, p<0.001); shorter visual distance when doing near-work activity (OR=1.17, p<0.001); and participation in an after-school tutorial program (OR=1.20, p<0.001). By contrast, resting after 30 minutes of near-work activity (OR=0.84, p<0.001) and spending more time participating in outdoor activities on weekends (OR=0.91, p=0.03) were significantly associated with a lower risk of myopia. Our findings indicate that lifestyle and reading habits impact the development of myopia during early childhood. Behavior modification, such as more time spent outside during the day and limited near-work activity, may be a feasible strategy for curbing the increasingly high prevalence of myopia in Taipei. Copyright © 2016. Published by Elsevier Taiwan LLC.

A visual approach to providing prognostic information to parents of children with retinoblastoma.

PubMed

Panton, Rachel L; Downie, Robert; Truong, Tran; Mackeen, Leslie; Kabene, Stefane; Yi, Qi-Long; Chan, Helen S L; Gallie, Brenda L

2009-03-01

Parents must rapidly assimilate complex information when a child is diagnosed with cancer. Education correlates with the ability to process and use medical information. Graphic tools aid reasoning and communicate complex ideas with precision and efficiency. We developed a graphic tool, DePICT (Disease-specific electronic Patient Illustrated Clinical Timeline), to visually display entire retinoblastoma treatment courses from real-time clinical data. We report retrospective evaluation of the effectiveness of DePICT to communicate risk and complexity of treatment to parents. We assembled DePICT graphics from multiple children on cards representing each stage of intraocular retinoblastoma. Forty-four parents completed a 14-item questionnaire to evaluate the understanding of retinoblastoma treatment and outcomes acquired from DePICT. As a proposed tool for informed consent, DePICT effectively communicated knowledge of complex medical treatment and risks, regardless of the education level. We identified multiple potential factors affecting parent comprehension of treatment complexity and risk. These include language proficiency (p=0.005) and age-related experience, as younger parents had higher education (p=0.021) but lower comprehension scores (p=0.011), regardless of first language. Provision of information at diagnosis concerning long-term treatment complexity helps parents of children with cancer. DePICT effectively transfers knowledge of treatments, risks, and prognosis in a manner that offsets parental educational disadvantages.

Development and Psychometric Evaluation of the HPV Clinical Trial Survey for Parents (CTSP‐HPV) Using Traditional Survey Development Methods and Community Engagement Principles

PubMed Central

Wallston, Kenneth A.; Wilkins, Consuelo H.; Hull, Pamela C.; Miller, Stephania T.

2015-01-01

Abstract Objective This study describes the development and psychometric evaluation of HPV Clinical Trial Survey for Parents with Children Aged 9 to 15 (CTSP‐HPV) using traditional instrument development methods and community engagement principles. Methods An expert panel and parental input informed survey content and parents recommended study design changes (e.g., flyer wording). A convenience sample of 256 parents completed the final survey measuring parental willingness to consent to HPV clinical trial (CT) participation and other factors hypothesized to influence willingness (e.g., HPV vaccine benefits). Cronbach's a, Spearman correlations, and multiple linear regression were used to estimate internal consistency, convergent and discriminant validity, and predictively validity, respectively. Results Internal reliability was confirmed for all scales (a ≥ 0.70.). Parental willingness was positively associated (p < 0.05) with trust in medical researchers, adolescent CT knowledge, HPV vaccine benefits, advantages of adolescent CTs (r range 0.33–0.42), supporting convergent validity. Moderate discriminant construct validity was also demonstrated. Regression results indicate reasonable predictive validity with the six scales accounting for 31% of the variance in parents’ willingness. Conclusions This instrument can inform interventions based on factors that influence parental willingness, which may lead to the eventual increase in trial participation. Further psychometric testing is warranted. PMID:26530324

Informed Consent in Pediatric Otolaryngology: What Risks and Benefits Do Parents Recall?

PubMed

Pianosi, Kiersten; Gorodzinsky, Ayala Y; Chorney, Jill MacLaren; Corsten, Gerard; Johnson, Liane B; Hong, Paul

2016-08-01

To evaluate parental recall of surgical risks and benefits in pediatric otolaryngology and to assess for factors that may influence recall. Prospective cohort study. Academic pediatric otolaryngology clinic. Eighty-four parents of children <6 years of age who underwent consultation for adeno/tonsillectomy and/or tympanostomy tube insertion were prospectively enrolled. Consultation visits were video recorded and the benefits and risks of surgery documented. Two weeks following the consultation, parents were contacted for assessment of recall of information discussed during the consultation. Overall, parents recalled only one-third of the risks of surgery mentioned by the surgeons. Parents were significantly more likely to recall the benefits of surgery as opposed to the risks (P < .001). Nine parents (10.7%) reported that no benefits were discussed during the consultation, and 10 (11.9%) reported no mention of any risks. Inconsistencies were present in which risks and benefits were mentioned by the providers. Parents who decided to proceed with surgery (58.3%) were significantly less likely to recall the surgical risks than those who did not (P < .001). The specific surgeon involved, the number of caregivers present, parental education level, and prior surgical history did not influence recall. Parental recall of benefits and risks associated with common pediatric otolaryngology procedures was poor. This information is important because a low rate of recall may influence parents' perspectives of the procedure and could alter their decision-making processes or expectations. Methods to improve parental recall should be further studied. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Testing an online, dynamic consent portal for large population biobank research.

PubMed

Thiel, Daniel B; Platt, Jodyn; Platt, Tevah; King, Susan B; Fisher, Nicole; Shelton, Robert; Kardia, Sharon L R

2015-01-01

Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Working with Private Access Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge. © 2014 S. Karger AG, Basel.

Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

PubMed

Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

2017-12-01

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States.

PubMed

Nelson, Suchitra; Milgrom, Peter

2012-01-01

To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. The study site was an urban school district with five elementary schools. Recruitment was carried out once each year for three years. Recruitment involved strategies at the school district, school, classroom, and student-parent level. A coalition of researchers, school personnel and community individuals was established for communication and recruitment. Outreach workers from the community were hired to promote, recruit, and disseminate oral health information. Study promotion included both print materials (logos, flyers, pictorial story boards) and presentations at school and community events. The School District Superintendent and administrators approved the study, and all five school principals and kindergarten teachers participated. All children within the classrooms were eligible: the overall participation rate of was 86% (580/672). Community outreach workers actively facilitated the recruitment and participants were recruited at open house for parent-teacher meeting (37% of all participants), sending letters and consent forms home (31%), at a prearranged convenient time during drop off and pick up of the child at their respective schools (30%), curriculum nights and health fairs (2%). Utilizing the social triad concept led to success in planning and carrying out the recruitment of predominantly minority school children with high participation rates. Copyright © 2011 Elsevier Inc. All rights reserved.

Minority Participation in a School-Based Randomized Clinical Trial of Tooth Decay Prevention in the United States

PubMed Central

Milgrom, Peter

2011-01-01

Purpose To describe the strategies--based on the social triad concept of a partnership of researchers, school personnel and community-- employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. Methods The study site was an urban school district with five elementary schools. Recruitment was carried out once each year for three years. Recruitment involved strategies at the school district, school, classroom, and student-parent level. A coalition of researchers, school personnel and community individuals was established for communication and recruitment. Outreach workers from the community were hired to promote, recruit, and disseminate oral health information. Study promotion included both print materials (logos, flyers, pictorial story boards) and presentations at school and community events. Results The School District Superintendent and administrators approved the study, and all five school principals and kindergarten teachers participated. All children within the classrooms were eligible: the overall participation rate of was 86% (580/672). Community outreach workers actively facilitated the recruitment and participants were recruited at open house for parent-teacher meeting (37% of all participants), sending letters and consent forms home (31%), at a prearranged convenient time during drop off and pick up of the child at their respective schools (30%), curriculum nights and health fairs (2%). Conclusion Utilizing the social triad concept led to success in planning and carrying out the recruitment of predominantly minority school children with high participation rates. PMID:21986390

A resolution to direct the Senate Legal Counsel to appear as amicus curiae in the name of the Senate in Menachem Binyamin Zivotofsky, By His Parents and Guardians, Ari Z. and Naomi Siegman Zivotofsky v. John Kerry, Secretary of State (S. Ct.).

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2014-07-16

Senate - 07/16/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Minors' rights to refuse medical treatment requested by their parents: remaining issues.

PubMed

Griswold, D P; Griswold, D B

2000-08-01

Nurse practitioners are regularly faced with ethical and legal dilemmas when providing care to minors. Laws may not provide clear direction; there may even be conflicting precedents regarding the status of minors, particularly with regard to the juvenile justice system. This article reviews the status of minors' rights with regard to refusing or consenting to medical tests or treatments. Three cases from one author's (DPG) practice illustrate the issues involved.

The prevalence of developmental dyscalculia in Brazilian public school system.

PubMed

Bastos, José Alexandre; Cecato, Angela Maria Traldi; Martins, Marielza Regina Ismael; Grecca, Kelly Regina Risso; Pierini, Rafael

2016-03-01

The goal of the study was to assess public school children at the end of the first stage of elementary school. We used a protocol applied concurrently with a writing test in the form of an unexpected activity in 28 public schools; 2,893 children assessed, 687 exhibited performance below 58 points, 184 were excluded due to change of address or lack of consent; 503 children subjected to a test of intellectual capacity and reading assessment and 71 considered intellectually disabled were excluded. 226 (7.8%) children, who could read, write, and had normal intellectual level, met the criteria of developmental dyscalculia (DD), 98 female and 128 male. The most influential factors in the prevalence were socioeconomic levels of the schools neighborhood, education level of parents, and being male, as demonstrated by the odds ratio and multiple logistic regression analysis. Further studies should be done so that educational policies are taken.

[National Disease Management Guideline for Asthma: recommendations and evidence for "asthma prevention" issues].

PubMed

Berdel, Dietrich; Buhl, Roland; Dierkesmann, Rainer; Niebling, Wilhelm; Schultz, Konrad; Ukena, Dieter; Worth, Heinrich; von Wichert, Peter; Ollenschläger, Günter; Kopp, Ina

2006-01-01

The National Disease Management Program (NDM Program) represents the basic content of structured, cross-sectoral healthcare. In particular, the NDM Program is directed towards coordinating different disciplines and areas of healthcare. The recommendations are developed through interdisciplinary consensus of the scientific medical societies on the basis of the best available evidence. Within this scope the scientific medical societies concerned with the prevention, diagnosis, therapy and rehabilitation of asthma consented upon a National Disease Management Guideline for Asthma in 2005. Among other things, the following cornerstones of asthma prevention were agreed upon: Breastfeeding and non-smoking were suggested as primary prevention measures for (expectant) parents. With respect to secondary prevention, recommendations have been made for allergen avoidance, active/passive smoking and immunotherapy. Regarding tertiary prevention, position statements on vaccination and specific immunotherapy are developed. The present paper presents both the original texts of the recommendations and the evidence underlying them.

Cohort profile: Ho Chi Minh City Youth Cohort--changes in diet, physical activity, sedentary behaviour and relationship with overweight/obesity in adolescents.

PubMed

Trang, Nguyen Hoang Hanh Doan; Hong, Tang Kim; Dibley, Michael John

2012-01-01

The Ho Chi Minh Youth cohort study aimed to assess the change in nutritional status; indicators of adiposity; diet; physical activity and sedentary behaviours; home, neighbourhood and school microenvironments and their complex relationships in adolescents in urban areas of Ho Chi Minh City. Prospective 5-year cohort. Systematic random sampling was used to select 18 schools in urban districts. Children were followed up over 5 years with an assessment in each year. Consent, from both adolescents and their parents, was required. At baseline, 759 students were recruited into the cohort, and of these students, 740 remained in the cohort for the first round, 712 for the second round, 630 for the third round and 585 for the last round of follow-up. Anthropometric measurements were taken using established guidelines. Six main groups of exposure factors including dietary intake and behaviours, physical activity and sedentary behaviours, family social and physical environment, school environment, socioeconomic status and parental characteristics were measured. Retention rate was high (77%). Within 5-year period, the prevalence of combined overweight and obesity using International Obesity Task Force cut-off values increased from 14.2% to 21.8%. Time spent on physical activity decreased significantly in the 5-year period from 87 to 50 min/day. Time spent on sedentary behaviours increased in the 5-year period from 512 to 600 min/day. The complete data analysis of this cohort study will allow a full exploration of the role of environmental and lifestyle behaviours on adolescent overweight and obesity and also identify the factors most strongly associated with excess weight gain and the appearance of overweight and obesity in different age groups of adolescents from this large city in Vietnam.

Recruitment and retention strategies and methods in the HEALTHY study.

PubMed

Drews, K L; Harrell, J S; Thompson, D; Mazzuto, S L; Ford, E G; Carter, M; Ford, D A; Yin, Z; Jessup, A N; Roullet, J-B

2009-08-01

HEALTHY was a 3-year middle school-based primary prevention trial to reduce modifiable risk factors for type 2 diabetes in youth. The study was conducted at seven centers across the country. This paper describes the recruitment and retention activities employed in the study. Schools and students were the focus of recruitment and retention. Each center was responsible for the recruitment of six schools; eligibility was based on ability to enroll a sufficient number of predominately minority and lower socioeconomic status students. Study staff met with district superintendents and school principals to verify the eligibility of schools, and to ascertain how appropriate the school would be for conducting the trial. Sixth grade students were recruited employing a variety of techniques; students and their parents did not know whether their school was randomized to the intervention or control arm. This cohort was followed through sixth, seventh and eighth grades. In the eighth grade, an additional sample of students who were not originally enrolled in the study was recruited in a similar manner to participate in data collection to allow for cross-sectional and dose-response secondary analyses. Parents signed informed consent forms and children signed informed assent forms, as per the needs of the local Institutional Review Board. Parents received a letter describing the results of the health screening for their children after data collection in sixth and eighth grades. Retention of schools and students was critical for the success of the study and was encouraged through the use of financial incentives and other strategies. To a large extent, student withdrawal due to out-migration (transfer and geographical relocation) was beyond the ability of the study to control. A multi-level approach that proactively addressed school and parent concerns was crucial for the success of recruitment and retention in the HEALTHY study.

Quality of life in pediatric cancer survivors: contributions of parental distress and psychosocial family risk

PubMed Central

Racine, N.M.; Khu, M.; Reynolds, K.; Guilcher, G.M.T.; Schulte, F.S.M.

2018-01-01

Background Pediatric survivors of childhood cancer are at increased risk of poor quality of life and social-emotional outcomes following treatment. The relationship between parent psychological distress and child adjustment in pediatric cancer survivors has been well established. However, limited research has examined the factors that may buffer this association. The current study examined the associations between psychosocial family risk factors, parental psychological distress, and health-related quality of life (hrql) in pediatric cancer survivors. Methods Fifty-two pediatric cancer survivors (34 males, 18 females, mean age = 11.92) and their parents were recruited from a long-term cancer survivor clinic. Children and their parents who consented to participate completed the Pediatric Quality of Life Inventory 4.0. Parents completed a demographic information form, the Psychosocial Assessment Tool (pat 2.0) and the Brief Symptom Inventory (bsi). The Intensity of Treatment Rating (itr-3) was evaluated by the research team. Results Multiple regression analyses revealed that parental psychological distress negatively predicted parent-reported hrql, while treatment intensity, gender, and psychosocial risk negatively predicted parent and child-reported hrql. Psychosocial risk moderated the association between parent psychological distress and parent-reported child hrql (p = 0.03), whereby parents with high psychological distress but low levels of psychosocial risk reported their children to have higher hrql. Conclusion Low levels of family psychosocial risk buffer the impact of parent psychological distress on child hrql in pediatric cancer survivors. The findings highlight the importance of identifying parents and families with at-risk psychological distress and psychosocial risk in order to provide targeted support interventions to mitigate the impact on hrql. PMID:29507482

Who has the right to advise children on birth control?

PubMed

Gerber, P; Rahemtula, A

1986-04-14

The Department of Health and Social Security (DHSS) in Great Britain issued "guidelines" to doctors in 1967 stating that it was permissible to give advice and contraceptive agents to underage females without parental consent. A Roman Catholic mother, Victoria Gillick, sought a declaration from the High Court of Justice that the DHSS guidelines were illegal. Gillick lost in the initial legal proceeding; the guidelines were held to be lawful. The Court of Appeal upheld Gillick's appeal 3 to none, only to be reversed later by a majority of 3 to 2 in the House of Lords. The various approaches that were adopted by the Court of Appeal and the House of Lords are reviewed. The issues can be reduced to this question: is a child of less than 16 years of age legally competent to seek contraceptive advice and treatment without the knowledge and consent of a parent or guardian. The Court of Appeal approached the problem assuming that the solution was to be found in the various Acts of Parliament, and it looked at every statute that dealt with children to learn what Parliament thought of parents. This inversion of emphasis received some recognition when the case reached the House of Lords: "parental rights to control a child do not exist for the benefit of the parent, they exist for the benefit of the child and they are justified only in so far as they enable the parent to perform his duties toward the child" (Lord Fraser). The Court of Appeal examined the Family Law Reform Act 1969, the Mental Health Act 1959, the Education Act 1944, and the Children Act 1975. From these various enactments, the Court of Appeal drew the following unanimous conclusions: that a parent or guardian has a parcel of rights in relation to a child in his or her custody, including the right to control the manner in which, and the place at which, the child spent his or her time, and that such rights could not, in general, be abandoned or transferred and would be enforced by the Court; that it was clearly recognized that there was some age below which a child was incapable, as a matter of law, of giving a valid consent or making a valid decision for itself in regard to its custody or upbringing, and the provisions of the criminal law showed that, in the matter of sexual intercourse, that age was 16 years for a girl; and that the circular which had been issued by the Department that stated a doctor could prescribe contraceptive agents for a girl 16 years of age without first informing her parents was illegal. A majority of the House of Lords concluded that the question of birth control for minors was essentially a medicosocial issue which, in exceptional circumstances, was best left to the clinical judgment of the appropriate health professionals, and that there was nothing in any statutory enactment which vested the exclusive right in a parent or guardian to permit or prohibit a girl below the age of 16 years to obtain professional advice or treatment relating to contraception. As the position in Australia remains fluid, and the decisions of the House of Lords are not binding, it is still possible that the statute-by-statute approach adopted by the Court of Appeal may find favor in Australia. A table sets out the relevant position on a State-by-State basis. It is concluded that the "right" to contraceptive advice and treatment involves the decision whether or not to have a child, and if the right of privacy means anything, it is the right of the individual to be free of unwarranted governmental intrusion in these matters, as held in a 1972 US Supreme Court decision.

Lowering the Age of Consent: Pushing Back against the Anti-Vaccine Movement.

PubMed

Whelan, Allison M

2016-09-01

This article examines the rise of the anti-vaccination movement, the proliferation of laws allowing parental exemptions to mandatory school vaccines, and the impact of the movement on immunization rates for all vaccines. It uses the ongoing debate about the Human Papillomavirus (HPV) vaccine as an example to highlight the ripple effect and consequences of the anti-vaccine movement despite robust evidence of the vaccine's safety and efficacy. The article scrutinizes how state legislatures ironically promote vaccination while simultaneously deferring to the opposition by promulgating broad opt-outs from mandatory vaccine laws. This article concludes by offering an alternative legislative approach to specifically combat the anti-vaccine movement's impact on HPV vaccination rates. Lowering the age of consent has not been widely attempted or proposed and provides an alternative statutory mechanism to push back against vaccine resistance. © 2016 American Society of Law, Medicine & Ethics.

Depressive symptoms in adolescence: The role of perceived parental support, psychological control, and proactive control in interaction with 5-HTTLPR.

PubMed

Van Assche, E; Moons, T; Van Leeuwen, K; Colpin, H; Verschueren, K; Van Den Noortgate, W; Goossens, L; Claes, S

2016-05-01

Parenting dimensions are associated with depressive symptoms in adolescents. We investigated the role of perceived parenting dimensions and gene-environment interactions between these perceived parenting dimensions and five well-known variable number of tandem repeats (VNTRs): 5-HTTLPR, STin2, DAT1, DRD4, and MAO-A, in depressive symptoms. From a non-clinical sample of 1111 Belgian adolescents (mean age: 13.79 years, SD=.94; 51% boys), 1103 adolescents consented for genetic research. Five VNTRs were analyzed using DNA from saliva samples. Perceived parenting dimensions (i.e., support, proactive control, psychological control, punishment, and harsh punishment) were examined using self-report scales completed by adolescents and their parents. Depressive symptoms were investigated using the CES-D self-report scale. Statistical analyses were performed in R using linear regression. Parental support, as perceived by the adolescent, was negatively associated with depressive symptoms (CES-D) and psychological control was positively associated with these symptoms. The only interaction effect withstanding correction for multiple testing was observed for 5-HTTLPR and the difference in proactive control as perceived by adolescents in comparison to parents. Short-allele carriers showed more depressive symptoms when there was a higher discrepancy in proactive control as perceived by adolescents versus parents. Our results suggest that perceived parenting dimensions are associated with depressive symptoms, as measured by the CES-D. We only found modest evidence for 5-HTTLPR as a moderator in the association between the difference in perception of proactive control (adolescents vs. parents) and depressive symptoms. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

"Watching time tick by…": Decision making for Duchenne muscular dystrophy trials.

PubMed

Peay, Holly L; Scharff, Hadar; Tibben, Aad; Wilfond, Benjamin; Bowie, Janice; Johnson, Joanna; Nagaraju, Kanneboyina; Escolar, Diana; Piacentino, Jonathan; Biesecker, Barbara B

2016-01-01

This interview study explored clinicians' perspectives and parents' decision making about children's participation in Duchenne muscular dystrophy (DMD) clinical trials. Data from semi-structured interviews conducted with clinicians and parents in U.S. or Canada were assessed using thematic analysis. Eleven clinicians involved in ten trials and fifteen parents involved in six trials were interviewed. Parents described benefit-risk assessments using information from advocacy, peers, professionals, and sponsors. Strong influence was attributed to the progressive nature of DMD. Most expected direct benefit. Few considered the possibility of trial failure. Most made decisions to participate before the informed consent (IC) process, but none-the-less perceived informed choice with little to lose for potential gain. Clinicians described more influence on parental decisions than attributed by parents. Clinicians felt responsible to facilitate IC while maintaining hope. Both clinicians and parents reported criticisms about the IC process and regulatory barriers. The majority of parents described undertaking benefit-risk assessments that led to informed choices that offered psychological and potential disease benefits. Parents' high expectations influenced their decisions while also reflecting optimism. Clinicians felt challenged in balancing parents' expectations and likely outcomes. Prognosis-related pressures coupled with decision making prior to IC suggest an obligation to ensure educational materials are understandable and accurate, and to consider an expanded notion of IC timeframes. Anticipatory guidance about potential trial failure might facilitate parents' deliberations while aiding clinicians in moderating overly-optimistic motivations. Regulators and industry should appreciate special challenges in progressive disorders, where doing nothing was equated with doing harm. Copyright © 2015 Elsevier Inc. All rights reserved.

Presenting Research Risks and Benefits to Parents: Does Format Matter?

PubMed Central

Tait, Alan R.; Voepel-Lewis, Terri; Zikmund-Fisher, Brian J.; Fagerlin, Angela

2012-01-01

Background/Aim Several studies suggest that many parents and research participants have poor understanding of the elements of consent, particularly the risks and benefits. However, some data suggest that the format and framing of research risks and benefits may be an important determinant of subject understanding. We examined the effect of tabular and graphical presentation of risks and benefits on parents’ understanding of a research study. Methods/Materials Parents of children scheduled to undergo an elective surgical procedure (N=408) were randomized to receive information about the risks and benefits of a sham study of postoperative pain control using text, tables, or pictographs and then completed a questionnaire to examine their gist (essential) and verbatim (actual) understanding of the information. Parent demographics were recorded and their literacy and numeracy skills measured. Results Parents randomized to receive information using tables or pictographs had significantly (P<0.025) greater gist and verbatim understanding compared with parents who received the information using standard text. Tables and pictographs were also superior to text in promoting understanding among parents with low numeracy and literacy skills. Conclusions Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment. This is due, in part, to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual. The results of this study suggest a simple and practical method for enhancing understanding of risk/benefit statistics for parents with varying numeracy and literacy skills. PMID:20686011

C-reactive protein point-of-care testing in acutely ill children: a mixed methods study in primary care.

PubMed

Van den Bruel, Ann; Jones, Caroline; Thompson, Matthew; Mant, David

2016-04-01

Point-of-care C-reactive protein (CRP) testing of adults with acute respiratory infection in primary care reduces antibiotic prescribing by 22%. The acceptability and impact of CRP testing in children is unknown To determine the acceptability and impact of CRP testing in acutely ill children. Mixed methods study comprising an observational cohort with a nested randomised controlled trial and embedded qualitative study. Children presenting with an acute illness to general practice out-of-hours services; children with a temperature ≥38°C were randomised in the nested trial; parents and clinical staff were invited to the qualitative study. Informed consent rates; parental and staff views on testing. Consent to involvement in the study was obtained for 200/297 children (67.3%, 95% CI 61.7% to 72.6%); the finger-prick test might have been a contributory factor for 63 of the 97 children declining participation but it was cited as a definite factor in only 10 cases. None of the parents or staff raised concerns about the acceptability of testing, describing the pain caused as minor and transient. General practitioner views on the utility of the CRP test were inconsistent. CRP point-of-care testing in children is feasible in primary care and is likely to be acceptable. However, it will not reduce antibiotic prescribing and hospital referrals until general practitioners accept its diagnostic value in children. ISRCTN 69736109. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Re J (A Minor) (Wardship: Medical Treatment)

PubMed

1992-06-10

The Civil Division of England's Court of Appeal overturned the lower court's order of mechanical ventilation for a profoundly handicapped sixteen-month-old child against the clinical judgment of the child's doctors. Since hitting his head in a fall at age four weeks, J had not mentally developed past that time and he was blind and he suffered from severe cerebral palsy and epilepsy. He required nasogastric tubal feeding and, although he occasionally responded to sound, whether or not he recognized his caregivers was uncertain. His divorced mother and the local authority shared parental authority over J, who resided with foster parents. The consultant pediatrician reported that if J were to suffer a life-threatening event, ordinary resuscitation, antibiotics and physiotherapy would be appropriate, but intervention with intensive measures including mechanical ventilation would be medically inappropriate. Two other specialists agreed with those findings, but another consultant found mechanical ventilation not to be cruel and thought J could be weaned from it if it became so. The mother and local health authority asked the court to require the health authority to continue all treatment, including mechanical ventilation, of J. The Official Solicitor and the health authority opposed such an order. The lower court granted an interim order requiring mechanical ventilation if necessary over the five weeks prior to the main hearing. The appellate court viewed such an order as an abuse of judicial power and held that the physician's duty to the patient is to treat with the necessary consent in accord with the best clinical judgment and that, as long as those with parental authority consent to J's treatment by the health authority, he must be treated in accord with the best clinical judgment of that authority's personnel.

Animal-assisted dyadic therapy: A therapy model promoting development of the reflective function in the parent-child bond.

PubMed

Shani, Liat

2017-01-01

Animal-assisted psychotherapy (AAP) inherently incorporates standpoints, interventions, and ways of action promoting the development of the reflective function and mentalization, and thus has special value for parent-child psychotherapy. Two central tools in AAP contribute to this process. The first is the ethical stance of the therapist, who sees the animals as full partners in the therapy situation, respecting them as subjects with needs, desires, and thoughts of their own. The second tool combines nonverbal communication with animals together with the relating, in the here and now, to the understanding and decoding of body language of everyone in the setting. Nonverbal communication in AAP enables access to implicit communication patterns occurring between parent and child. This article provides a survey of theoretical development and research constituting a basis for the development of therapeutic approaches for the improvement of parent-children dynamics, followed by a description of a dyadic therapy model of a mentalization-based treatment originating from a psychoanalytic-relational orientation. Clinical examples are provided to illustrate AAP processes in parent-child psychotherapy (consent was received for examples that were not aggregated).

A comparative study of expectant parents ' childbirth expectations.

PubMed

Kao, Bi-Chin; Gau, Meei-Ling; Wu, Shian-Feng; Kuo, Bih-Jaw; Lee, Tsorng-Yeh

2004-09-01

The purpose of this study was to understand childbirth expectations and differences in childbirth expectations among expectant parents. For convenience sampling, 200 couples willing to participate in this study were chosen from two hospitals in central Taiwan. Inclusion criteria were at least 36 weeks of gestation, aged 18 and above, no prenatal complications, and willing to consent to participate in this study. Instruments used to collect data included basic demographic data and the Childbirth Expectations Questionnaire. Findings of the study revealed that (1) five factors were identified by expectant parents regarding childbirth expectations including the caregiving environment, expectation of labor pain, spousal support, control and participation, and medical and nursing support; (2) no general differences were identified in the childbirth expectations between expectant fathers and expectant mothers; and (3) expectant fathers with a higher socioeconomic status and who had received prenatal (childbirth) education had higher childbirth expectations, whereas mothers displayed no differences in demographic characteristics. The study results may help clinical healthcare providers better understand differences in expectations during labor and birth and childbirth expectations by expectant parents in order to improve the medical and nursing system and promote positive childbirth experiences and satisfaction for expectant parents.

Adolescents' attitudes and experiences regarding levonorgestrel 100 mcg/ethinyl estradiol 20 mcg.

PubMed

Rosenthal, S L; Cotton, S; Ready, J N; Potter, L S; Succop, P A

2002-12-01

Oral contraceptive pills (OCs) are a commonly prescribed method of birth control for sexually experienced adolescents. The purpose of the current study was to describe anticipated parental involvement and adolescent compliance with pill taking, and to describe experiences with a 20-mcg OC regarding satisfaction and side effects after six cycles. Anticipated parental involvement and anticipated compliance, and experiences with an OC, were assessed at baseline, and after the first and sixth cycles during a clinical trial of oral contraceptives, which required parental consent. Three adolescent medicine clinics in New York, NY; Cincinnati, OH; and San Juan, Puerto Rico. The sample consisted of 43 female adolescents with a mean age of 17 years. The majority of adolescents living with a parent anticipated parental involvement, and few adolescents anticipated difficulties with consistent pill taking. For two side effects (weight and mood changes), more than 30% of the adolescents anticipated the occurrence or worsening of side effects. However, few adolescents actually experienced increases in any of the nine side effects assessed. Ninety-seven percent of adolescents in this trial reported being satisfied with a 20-mcg OC. Health care providers can assess adolescents' anticipated difficulties with compliance with daily pill taking, and desire for help from their parents. This information can be incorporated into counseling to promote consistent and correct use.

A Pilot Study of Changes in Environmental Knowledge and Behaviors among Head Start Employees and Parents Following Environmental Health Training in Webb County, TX.

PubMed

Trueblood, Amber B; Rincon, Rudy; Perales, Roger; Hollingsworth, Ryan; Miller, Claudia; McDonald, Thomas J; Cizmas, Leslie

2016-02-01

Head Start centers in Webb County, Texas primarily serve low-income Hispanic families disproportionately affected by environmental exposures. A total of 560 parents and employees attended environmental trainings. Pre- and post-assessments measured whether the trainings were effective at improving related knowledge and behaviors. A total of 152 parents and 94 employees signed consent forms. Only the 64 parents and 50 employees who completed all questionnaires were included in the data analysis. Paired t tests and McNemar tests found significant improvements in knowledge and behaviors related to multiple environmental topics (p < 0.05). Mean scores out of eleven for knowledge before and immediately after were 9.69 (95 % CI 9.44, 9.94) and 10.58 (95 % CI 10.42, 10.74), respectively. Mean scores out of ten for behavior before and 1 month after training were 8.00 (95 % CI 7.71, 8.29) and 9.29 (95 % CI 9.10, 9.48), respectively. This pilot study found improved knowledge and behaviors following environmental health training.

Re-recruiting young adult women into a second follow-up study.

PubMed

Mohan, Yasmina; Cornejo, Melissa; Sidell, Margo; Smith, Jessica; Young, Deborah Rohm

2017-03-01

Recruitment among young adults presents a unique set of challenges as they are difficult to reach through conventional methods. To describe our experience using both traditional and nontraditional methods in the re-recruitment of young adult women into the second follow-up study of the Trial of Activity for Adolescent Girls (TAAG). 589 adolescent girls were re-recruited as 11th graders into TAAG 2. Re-recruitment efforts were conducted when they were between 22 and 23 years of age (TAAG 3). Facebook, email, postal mail, and telephone (call and text) were used. Descriptive statistics were used to summarize cohort characteristics. Discrete categorical variables were compared using Pearson chi-square or Fisher's exact test, while Wilcoxon rank sum or t-tests were calculated for continuous variables. Pearson's chi square test, analysis of variance, and the Kruskal-Wallis test were also used. Logistic regression was used to calculate adjusted models. All 589 cohort members were located and 479 (81.3%) were re-recruited. Participants who reported living in a two parent household or with their mothers only, and who did not perceive a lot of crime in their neighborhood were more likely to consent to participate in TAAG 3 (p = 0.047 and p = 0.008, respectively). Perceived neighborhood crime remained significant in the adjusted model (OR 0.48, 95% CI 0.25-0.90, p = 0.02). Early and late consenters differed by race/ethnicity (p = 0.015), household type (p = 0.001), and socioeconomic status (p = 0.005). In the adjusted model, Black participants were more likely to consent later than White participants (OR 1.83, 95% CI 1.07-3.13, p = 0.03). A number of recruitment strategies and outreach attempts were needed to recruit young adult women into a follow-up study. Persistent efforts may be needed to recruit participants with race/ethnic diversity and lower socioeconomic status.

To Consent or Decline HPV Vaccination: A Pilot Study at the Start of the National School-Based Vaccination Program in Sweden.

PubMed

Grandahl, Maria; Tydén, Tanja; Westerling, Ragnar; Nevéus, Tryggve; Rosenblad, Andreas; Hedin, Erik; Oscarsson, Marie

2017-01-01

Parents' beliefs about human papillomavirus (HPV) vaccination influence whether they allow their daughters to be vaccinated. We examined the association between parents' refusal and sociodemographic background, knowledge and beliefs about HPV, and the HPV vaccination in relation to the Health Belief Model. The sample consisted of 200 (55%) parents of children aged 11-12 years in the Swedish national vaccination program. Data were collected using a self-reported questionnaire. Most parents (N = 186) agreed to the vaccination. Pearson's chi-square, Fisher's exact test, and the Mann-Whitney U test were used to analyze data. Declining parents saw more risks and fewer benefits of HPV vaccination but no differences in beliefs regarding the severity or young girls' susceptibility to HPV were found. There was an association between refusing the HPV vaccine and lower acceptance of previous childhood vaccinations, and their main source of information was the Internet. Parents who declined the vaccine believed it could adversely affect condom use, the age of their daughter's sexual debut, and the number of sexual partners. Parents should have the possibility to discuss HPV and HPV vaccine with a school nurse or other health care professionals, and should have access to evidence-based information on the Internet. © 2016 The Authors. Journal of School Health published by Wiley Periodicals, Inc. on behalf of American School Health Association.

Rapid prenatal diagnosis using targeted exome sequencing: a cohort study to assess feasibility and potential impact on prenatal counseling and pregnancy management.

PubMed

Chandler, Natalie; Best, Sunayna; Hayward, Jane; Faravelli, Francesca; Mansour, Sahar; Kivuva, Emma; Tapon, Dagmar; Male, Alison; DeVile, Catherine; Chitty, Lyn S

2018-03-29

PurposeUnexpected fetal abnormalities occur in 2-5% of pregnancies. While traditional cytogenetic and microarray approaches achieve diagnosis in around 40% of cases, lack of diagnosis in others impedes parental counseling, informed decision making, and pregnancy management. Postnatally exome sequencing yields high diagnostic rates, but relies on careful phenotyping to interpret genotype results. Here we used a multidisciplinary approach to explore the utility of rapid fetal exome sequencing for prenatal diagnosis using skeletal dysplasias as an exemplar.MethodsParents in pregnancies undergoing invasive testing because of sonographic fetal abnormalities, where multidisciplinary review considered skeletal dysplasia a likely etiology, were consented for exome trio sequencing (both parents and fetus). Variant interpretation focused on a virtual panel of 240 genes known to cause skeletal dysplasias.ResultsDefinitive molecular diagnosis was made in 13/16 (81%) cases. In some cases, fetal ultrasound findings alone were of sufficient severity for parents to opt for termination. In others, molecular diagnosis informed accurate prediction of outcome, improved parental counseling, and enabled parents to terminate or continue the pregnancy with certainty.ConclusionTrio sequencing with expert multidisciplinary review for case selection and data interpretation yields timely, high diagnostic rates in fetuses presenting with unexpected skeletal abnormalities. This improves parental counseling and pregnancy management.Genetics in Medicine advance online publication, 29 March 2018; doi:10.1038/gim.2018.30.

Strengthening the Role of Families in States' Early Intervention Systems: Policy Guide to Procedural Safeguards for Infants and Toddlers and Their Families under Part H of the Education of the Handicapped Act.

ERIC Educational Resources Information Center

Burnim, Ira A.

This book presents recommended policies and procedural safeguards for programs serving infants, toddlers and their families under Part H of the Education of the Handicapped Act. Policies are presented in five chapters covering: (1) consent to assessment, evaluation and services; (2) notice of parents' rights and of proposed actions; (3) right to…

A resolution congratulating the students, parents, teachers, and administrators of charter schools across the United States for their ongoing contributions to education, and supporting the ideals and goals of the 15th annual National Charter Schools Week, to be held May 4 through May 10, 2014.

THOMAS, 113th Congress

Sen. Landrieu, Mary L. [D-LA

2014-05-06

Senate - 05/06/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution congratulating the students, parents, teachers, and administrators of charter schools across the United States for ongoing contributions to education and supporting the ideals and goals of the 11th annual National Charter Schools Week, to be held May 2 through May 8, 2010.

THOMAS, 111th Congress

Sen. Landrieu, Mary L. [D-LA

2010-05-05

Senate - 05/05/2010 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution congratulating the students, parents, teachers, and administrators of charter schools across the United States for ongoing contributions to education, and supporting the ideals and goals of the 13th annual National Charter Schools Week, to be held May 6 through May 12, 2012.

THOMAS, 112th Congress

Sen. Landrieu, Mary L. [D-LA

2012-05-08

Senate - 05/08/2012 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution congratulating the students, parents, teachers, and administrators at charter schools across the United States for their ongoing contributions to education and supporting the ideas and goals of the 10th annual National Charter Schools Week, May 3 through May 9, 2009.

THOMAS, 111th Congress

Sen. Landrieu, Mary L. [D-LA

2009-05-06

Senate - 05/06/2009 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

An evaluation of "informed consent" with volunteer prisoner subjects.

PubMed

Marini, J L; Sheard, M H; Bridges, C I

1976-11-01

"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.

Sexual and Gender Minority Adolescents' Views On HIV Research Participation and Parental Permission: A Mixed-Methods Study.

PubMed

Mustanski, Brian; Coventry, Ryan; Macapagal, Kathryn; Arbeit, Miriam R; Fisher, Celia B

2017-06-01

Sexual and gender minority adolescents are underrepresented in HIV research, partly because institutional review boards (IRBs) are reluctant to waive parental permission requirements for these studies. Understanding teenagers' perspectives on parental permission and the risks and benefits of participating in HIV research is critical to informing evidence-based IRB decisions. Data from 74 sexual and gender minority adolescents aged 14-17 who participated in an online focus group in 2015 were used to examine perspectives on the risks and benefits of participation in a hypothetical HIV surveillance study and the need for parental permission and adequate protections. Data were analyzed thematically; mixed methods analyses examined whether concerns about parental permission differed by whether teenagers were out to their parents. Most adolescents, especially those who were not out to their parents, would be unwilling to participate in an HIV study if parental permission were required. Perceived benefits of participation included overcoming barriers to HIV testing and contributing to the health of sexual and gender minority youth. Few risks of participation were identified. Adolescents suggested steps that researchers could take to facilitate informed decision making about research participation and ensure minors' safety in the absence of parental permission; these included incorporating multimedia presentations into the consent process and explaining researchers' motivations for conducting the study. Respondents believed that the benefits of HIV surveillance research outweighed the risks. Requiring parental permission may exclude many sexual and gender minority teenagers from taking part in HIV research, especially if they are not out. Copyright © 2017 by the Guttmacher Institute.

Sexual and Gender Minority Adolescents’ Views on HIV Research Participation and Parental Permission: A Mixed- Methods Study

PubMed Central

Mustanski, Brian; Coventry, Ryan; Macapagal, Kathryn; Arbeit, Miriam R.; Fisher, Celia B.

2018-01-01

CONTEXT Sexual and gender minority adolescents are underrepresented in HIV research, in part because institutional review boards (IRBs) are reluctant to waive parental permission requirements for these studies. Understanding teenagers’ perspectives on parental permission and the risks and benefits of participating in HIV research is critical to informing evidence-based IRB decisions. METHODS Data from 74 sexual and gender minority adolescents aged 14–17 who participated in an online focus group in 2015 were used to examine perspectives on the risks and benefits of participation in a hypothetical HIV surveillance study and on the need for parental permission and adequate protections. Data were analyzed thematically; mixed methods analyses examined whether concerns about parental permission differed by whether teenagers were out to their parents. RESULTS Most adolescents, especially those who were not out to their parents, would be unwilling to participate in an HIV study if parental permission were required. Perceived benefits of participation included overcoming barriers to HIV testing and contributing to the health of sexual and gender minority youth. Few risks of participation were identified. Adolescents suggested several steps that researchers could take to facilitate informed decision making about research participation and ensure minors’ safety in the absence of parental permission; these included incorporating multimedia presentations into the consent process and explaining researchers’ motivations for conducting the study. CONCLUSIONS Respondents believed that the benefits of HIV surveillance research outweighed the risks. Requiring parental permission may exclude many sexual and gender minority teenagers from taking part in HIV research, especially if they are not out. PMID:28445608

Do State-Based Policies Have an Impact on Teen Birth Rates and Teen Abortion Rates in the United States?

PubMed

Chevrette, Marianne; Abenhaim, Haim Arie

2015-10-01

The United States has one of the highest teen birth rates among developed countries. Interstate birth rates and abortion rates vary widely, as do policies on abortion and sex education. The objective of our study is to assess whether US state-level policies regarding abortion and sexual education are associated with different teen birth and teen abortion rates. We carried out a state-level (N = 51 [50 states plus the District of Columbia]) retrospective observational cross-sectional study, using data imported from the National Vital Statistics System. State policies were obtained from the Guttmacher Institute. We used descriptive statistics and regression analysis to study the association of different state policies with teen birth and teen abortion rates. The state-level mean birth rates, when stratifying between policies protective and nonprotective of teen births, were not statistically different-for sex education policies, 39.8 of 1000 vs 45.1 of 1000 (P = .2187); for mandatory parents' consent to abortion 45 of 1000, vs 38 of 1000 when the minor could consent (P = .0721); and for deterrents to abortion, 45.4 of 1000 vs 37.4 of 1000 (P = .0448). Political affiliation (35.1 of 1000 vs 49.6 of 1000, P < .0001) and ethnic distribution of the population were the only variables associated with a difference between mean teen births. Lower teen abortion rates were, however, associated with restrictive abortion policies, specifically lower in states with financial barriers, deterrents to abortion, and requirement for parental consent. While teen birth rates do not appear to be influenced by state-level sex education policies, state-level policies that restrict abortion appear to be associated with lower state teen abortion rates. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

12 CFR 347.119 - Specific consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... processing procedure. (d) Specific consent. Direct or indirect investments in or activities of foreign... control such organization as a result of a foreign investment; or (ii) A bank would be establishing a... foreign country. (1) Applicable law or practice in the foreign country where the foreign organization or...

77 FR 76072 - Notice of Extension to Public Comment Period for Remedial Design/Remedial Action Consent Decree...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... activities, the RD/RA Consent Decree requires the Defendants to reimburse EPA for its oversight of work... Decree Library, U.S. DOJ--ENRD, P.O. Box 7611, Washington, DC 20044-7611. Please enclose a check or money...

Social Physique Anxiety and Intention to Be Physically Active: A Self-Determination Theory Approach.

PubMed

Sicilia, Álvaro; Sáenz-Alvarez, Piedad; González-Cutre, David; Ferriz, Roberto

2016-12-01

Based on self-determination theory, the purpose of this study was to analyze the relationship between social physique anxiety and intention to be physically active, while taking into account the mediating effects of the basic psychological needs and behavioral regulations in exercise. Having obtained parents' prior consent, 390 students in secondary school (218 boys, 172 girls; M age  = 15.10 years, SD = 1.94 years) completed a self-administered questionnaire during physical education class that assessed the target variables. Preliminary analyses included means, standard deviations, and bivariate correlations among the target variables. Next, a path analysis was performed using the maximum likelihood estimation method with the bootstrapping procedure in the statistical package AMOS 19. Analysis revealed that social physique anxiety negatively predicted intention to be physically active through mediation of the basic psychological needs and the 3 autonomous forms of motivation (i.e., intrinsic motivation, integrated regulation, and identified regulation). The results suggest that social physique anxiety is an internal source of controlling influence that hinders basic psychological need satisfaction and autonomous motivation in exercise, and interventions aimed at reducing social physique anxiety could promote future exercise.

The effect of informed consent on stress levels associated with extraction of impacted mandibular third molars.

PubMed

Casap, Nardy; Alterman, Michael; Sharon, Guy; Samuni, Yuval

2008-05-01

To evaluate the effect of informed consent on stress levels associated with removal of impacted mandibular third molars. A total of 60 patients scheduled for extraction of impacted mandibular third molars participated in this study. The patients were unaware of the study's objectives. Data from 20 patients established the baseline levels of electrodermal activity (EDA). The remaining 40 patients were randomly assigned into 2 equal groups receiving either a detailed document of informed consent, disclosing the possible risks involved with the surgery, or a simplified version. Pulse, blood pressure, and EDA were monitored before, during, and after completion of the consent document. Changes in EDA, but not in blood pressure, were measured on completion of either version of the consent document. A greater increase in EDA was associated with the detailed version of the consent document (P = .004). A similar concomitant increase (although nonsignificant) in pulse values was monitored on completion of both versions. Completion of overdisclosed document of informed consent is associated with changes in physiological parameters. The results suggest that overdetailed listing and disclosure before extraction of impacted mandibular third molars can increase patient stress.

Knowledge, attitude, and practices of oral health care in prevention of early childhood caries among parents of children in Belagavi city: A Questionnaire study.

PubMed

Suma Sogi, H P; Hugar, Shivayogi M; Nalawade, Triveni Mohan; Sinha, Anjali; Hugar, Shweta; Mallikarjuna, Rachappa M

2016-01-01

The aim of this study was to assess the existing knowledge, attitude, and practices of "oral health care" in the prevention of early childhood caries (ECCs) among parents of children in Belagavi city. A cross-sectional study was conducted in the outpatient Department of Pedodontics and Preventive Dentistry, KLE VK Institute of Dental Sciences, Belagavi, Karnataka. Institutional Ethical Clearance was obtained. The study was conducted during the month of April 2014 to October 2014 after taking prior informed consent from the 218 parents. Inclusion criteria were parents getting their children treated for dental caries and who were willing to participate. Parents who could not read and write were excluded from the study. The self-administered, close-ended questionnaire was written in English. It was then translated in local languages, i.e. Kannada and Marathi, and a pilot study was conducted on 10 parents to check for its feasibility and any changes if required were done. The response rate was 100% as all 218 parents completed the questionnaire. Of 218 parents, 116 were mothers and 102 were fathers. The overall mean knowledge score was 69.5%. The overall mean attitude score was 53.5%. The overall attitude toward prevention of ECC was not in accordance to knowledge. The overall mean of "good" practices and "bad" practices score was 33.5% and 18.5%, respectively. Good knowledge and attitude toward oral health do not necessarily produce good practices.

Parenting, relational aggression, and borderline personality features: associations over time in a Russian longitudinal sample.

PubMed

Nelson, David A; Coyne, Sarah M; Swanson, Savannah M; Hart, Craig H; Olsen, Joseph A

2014-08-01

Crick, Murray-Close, and Woods (2005) encouraged the study of relational aggression as a developmental precursor to borderline personality features in children and adolescents. A longitudinal study is needed to more fully explore this association, to contrast potential associations with physical aggression, and to assess generalizability across various cultural contexts. In addition, parenting is of particular interest in the prediction of aggression or borderline personality disorder. Early aggression and parenting experiences may differ in their long-term prediction of aggression or borderline features, which may have important implications for early intervention. The currrent study incorporated a longitudinal sample of preschool children (84 boys, 84 girls) living in intact, two-parent biological households in Voronezh, Russia. Teachers provided ratings of children's relational and physical aggression in preschool. Mothers and fathers also self-reported their engagement in authoritative, authoritarian, permissive, and psychological controlling forms of parenting with their preschooler. A decade later, 70.8% of the original child participants consented to a follow-up study in which they completed self-reports of relational and physical aggression and borderline personality features. The multivariate results of this study showed that preschool relational aggression in girls predicted adolescent relational aggression. Preschool aversive parenting (i.e., authoritarian, permissive, and psychologically controlling forms) significantly predicted aggression and borderline features in adolescent females. For adolescent males, preschool authoritative parenting served as a protective factor against aggression and borderline features, whereas authoritarian parenting was a risk factor for later aggression.

Improving survey response rates from parents in school-based research using a multi-level approach.

PubMed

Schilpzand, Elizabeth J; Sciberras, Emma; Efron, Daryl; Anderson, Vicki; Nicholson, Jan M

2015-01-01

While schools can provide a comprehensive sampling frame for community-based studies of children and their families, recruitment is challenging. Multi-level approaches which engage multiple school stakeholders have been recommended but few studies have documented their effects. This paper compares the impact of a standard versus enhanced engagement approach on multiple indicators of recruitment: parent response rates, response times, reminders required and sample characteristics. Parents and teachers were distributed a brief screening questionnaire as a first step for recruitment to a longitudinal study, with two cohorts recruited in consecutive years (cohort 1 2011, cohort 2 2012). For cohort 2, additional engagement strategies included the use of pre-notification postcards, improved study materials, and recruitment progress graphs provided to school staff. Chi-square and t-tests were used to examine cohort differences. Compared to cohort 1, a higher proportion of cohort 2 parents responded to the survey (76% versus 69%; p < 0.001), consented to participate (71% versus 56%; p < 0.001), agreed to teacher participation (90% versus 82%; p < 0.001) and agreed to follow-up contact (91% versus 80%; p < 0.001). Fewer cohort 2 parents required reminders (52% versus 63%; p < 0.001), and cohort 2 parents responded more promptly than cohort 1 parents (mean difference: 19.4 days, 95% CI: 18.0 to 20.9, p < 0.001). These results illustrate the value of investing in a relatively simple multi-level strategy to maximise parent response rates, and potentially reduce recruitment time and costs.

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation.

PubMed

de Vries, Martine C; Wit, Jan M; Engberts, Dirk P; Kaspers, Gertjan J L; van Leeuwen, Evert

2010-07-15

Various regulations and guidelines stipulate the importance of involving adolescents in decision-making concerning research participation. Several studies have shown that in the context of pediatric oncology this involvement is difficult to achieve due to emotional stress, the complexity of research protocols and limited time. Still, up to 80% of adolescents with cancer enter onto a trial during their illness. The aim of this study was to determine clinicians' views and attitudes towards enrolling adolescents in research, considering the difficulties surrounding their involvement in decision-making. A qualitative multicenter study was performed, using in-depth semi-structured interviews on the informed consent process with 15 pediatric hemato-oncologists. Four central themes emerged that characterize clinicians' attitudes towards involving adolescents in the decision-making process: (1) clinicians regard most adolescents as not capable of participating meaningfully in discussions regarding research; (2) clinicians do not always provide adolescents with all information; (3) proxy consent from parents is obtained and is deemed sufficient; (4) clinician-investigator integrity: clinicians judge research protocols as not being harmful and even in the best interest of the adolescent. Clinicians justify not involving adolescents in research discussions by referring to best interest arguments (adolescents' incompetence, proxy consent, and investigator integrity), although this is not in line with legal regulations and ethical guidelines.

An easy test but a hard decision: ethical issues concerning non-invasive prenatal testing for autosomal recessive disorders

PubMed Central

Skirton, Heather; Goldsmith, Lesley; Chitty, Lyn S

2015-01-01

Prenatal testing based on cell-free fetal DNA in maternal serum is now possible for specific monogenic conditions, and studies have shown that the use of non-invasive testing is supported by prospective parents and health professionals. However, some ethical issues have been raised concerning informed consent and paternal rights. The objective of this study was to explore ethical aspects of the use of non-invasive prenatal diagnostic testing for autosomal recessive disorders. We used a qualitative cross-sectional design, based on Thematic Analysis, and recruited 27 individuals of reproductive age who were carriers of one of four conditions: thalassaemia, sickle cell disease, cystic fibrosis or spinal muscular atrophy. Data were collected via focus groups or interviews. Participants were aware of the potential for such tests to be viewed as routine and suggested that obtaining written consent and allowing time for consideration is needed to facilitate autonomous choice and informed consent. All participants felt that mothers should be able to request such tests, but fathers who declined carrier testing should be made aware that fetal test results may reveal their status. We suggest that a written record of consent for non-invasive prenatal diagnosis should be used as a standard to help reinforce the serious nature of the test results. Where the father's carrier status could be revealed through fetal testing, he should be made aware of this before the results are available. Health professionals should discuss with the pregnant woman the best way to manage unsought information about the father's carrier status to minimise family disruption. PMID:25351779

75 FR 25268 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are...-796-5156, email: [email protected] . SUPPLEMENTARY INFORMATION: In the Federal Register of...

75 FR 27781 - Agency Information Collection Activities: Proposed Collection Renewals; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... respondent burden, invites the general public and other Federal agencies to take this opportunity to comment... information titled: Application For Consent to Exercise Trust Powers (3064-0025), and Insurance Sales Consumer...: 1. Title: Application for Consent to Exercise Trust Powers. OMB Number: 3064-0025. Form Number: FDIC...

Low cultural identification, low parental involvement and adverse peer influences as risk factors for delinquent behaviour among Filipino youth in Hawai'i.

PubMed

Guerrero, Anthony P S; Nishimura, Stephanie T; Chang, Janice Y; Ona, Celia; Cunanan, Vanessa L; Hishinuma, Earl S

2010-07-01

Among Filipino youth in Hawai'i, low Filipino cultural identification and low family support may be important risk factors for delinquency. To examine, in a sample of Filipino youth in Hawai'i, correlations between delinquent behaviour and the aforementioned - as well as other, potentially mediating - variables. A youth risk survey and Filipino Culture Scale were administered to Filipino students (N = 150) in Hawai'i. A parent risk survey was administered to available and consenting parents. Delinquent behaviour correlated positively with acculturative stress, low cultural identification and adverse peer influences; and negatively with total Filipino Culture Scale score. Structural equation modelling suggested that absent/ineffective adults and adverse peer influences might be more important variables compared to low self-esteem and less religiosity, linking low cultural identification to delinquent behaviour. Although further studies are warranted, to be effective, efforts to prevent delinquency by enhancing Filipino youths' cultural connectedness may also need to enhance family connectedness and address adverse peer influences.

Parents' perceptions of child feeding: a qualitative study based on the theory of planned behavior.

PubMed

Duncanson, Kerith; Burrows, Tracy; Holman, Brett; Collins, Clare

2013-05-01

The aim of this qualitative study was to investigate the child-feeding behaviors and attitudes of parents of children aged 2 to 5 years, within the theory of planned behavior (TPB) framework. Semistructured telephone interviews were conducted in October 2011. The interviewer conducted and recorded the interviews from a community health center, to interviewees who were in their own home environment. Verbatim transcription of interviews preceded manual coding of data. Emergent themes were mapped into a matrix against a priori-coded TPB constructs (attitudes, beliefs, subjective norms, perceived behavioral control, and behavioral intention). Twenty-one consenting parents participated in interviews. Participants were predominantly tertiary-educated (65%) mothers (85%) who were older than 30 years (76%). Parents believed that optimal child nutrition is important but difficult to achieve. Behavioral intention to change feeding practices was limited by a belief that child's dietary intake is above average compared with their peer group. Perceived control over child dietary intake was influenced by food advertising, extended family, and peer influences. Parents supported targeting nutrition education directly at children and a policy approach to offset the costs of fresh foods by taxing "junk" foods. The application of TPB to child feeding may explain the disparity between parents' child-feeding intentions and behaviors. Parents' feeding behaviors are more influenced by peers than by dietary guidelines. Future interventions need to target parents' perceived child-feeding responsibilities, influence subjective norms, and increase parents' perceived control over child feeding. Peer nutrition education is proposed as an intervention model.

Use of online health information to manage children's health care: a prospective study investigating parental decisions.

PubMed

Walsh, Anne M; Hamilton, Kyra; White, Katherine M; Hyde, Melissa K

2015-04-02

The use of the internet to access information is rapidly increasing; however, the quality of health information provided on various online sites is questionable. We aimed to examine the underlying factors that guide parents' decisions to use online information to manage their child's health care, a behaviour which has not yet been explored systematically. Parents (N = 391) completed a questionnaire assessing the standard theory of planned behaviour (TPB) measures of attitude, subjective norm, perceived behavioural control (PBC), and intention as well as the underlying TPB belief-based items (i.e., behavioural, normative, and control beliefs) in addition to a measure of perceived risk and demographic variables. Two months later, consenting parents completed a follow-up telephone questionnaire which assessed the decisions they had made regarding their use of online information to manage their child's health care during the previous 2 months. We found support for the TPB constructs of attitude, subjective norm, and PBC as well as the additional construct of perceived risk in predicting parents' intentions to use online information to manage their child's health care, with further support found for intentions, but not PBC, in predicting parents' behaviour. The results of the TPB belief-based analyses also revealed important information about the critical beliefs that guide parents' decisions to engage in this child health management behaviour. This theory-based investigation to understand parents' motivations and online information-seeking behaviour is key to developing recommendations and policies to guide more appropriate help-seeking actions among parents.

A resolution recognizing National Foster Care Month as an opportunity to raise awareness about the challenges faced by children in the foster care system, acknowledging the dedication of foster care parents, advocates, and workers, and encouraging Congress to implement policy to improve the lives of children in the foster care system.

THOMAS, 112th Congress

Sen. Landrieu, Mary L. [D-LA

2012-05-16

Senate - 06/04/2012 Resolution agreed to in Senate without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution congratulating the students, parents, teachers, and administrators of charter schools across the United States for their ongoing contributions to education, and supporting the ideals and goals of the 14th annual National Charter Schools Week, to be celebrated the week of May 5 through May 11, 2013.

THOMAS, 113th Congress

Sen. Landrieu, Mary L. [D-LA

2013-05-09

Senate - 05/09/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Why is it hard to make progress in assessing children's decision-making competence?

PubMed

Hein, Irma M; Troost, Pieter W; Broersma, Alice; de Vries, Martine C; Daams, Joost G; Lindauer, Ramón J L

2015-01-10

For decades, the discussion on children's competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children's interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children's competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children's competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children's medical decision-making competence. Understanding children's competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child's decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children's competency, in which the most prominent question concerns the lack of a clear operationalization of children's competence to consent. Empirical data are needed to substantiate the discussion. The empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

Population density and refractive error among Chinese children.

PubMed

Zhang, Mingzhi; Li, Liping; Chen, Lizhen; Lee, Jack; Wu, Jiasi; Yang, Amy; Chen, Connie; Xu, Daocheng; Lam, Dennis S C; Sharma, Abhishek; Griffiths, Sian; Gao, Yang; Congdon, Nathan

2010-10-01

China is urbanizing rapidly, and the prevalence of myopia is high. This study was conducted to identify the reasons for observed differences in the prevalence of myopia among urban versus rural Chinese children. All children with uncorrected acuity of 6/12 or worse and a 50% random sample of children with vision better than 6/12 at all secondary schools in mixed rural-urban Liangying Township, Guangdong, underwent cycloplegic refraction, and provided data on age, gender, parental education, weekly near work and time outdoors, and urban development level of respondents' neighborhoods (12-item questionnaire). Population density of 32 villages and urban zones in Liangying was calculated from census figures (mean population density, 217 persons/km(2); range, 94-957; mean for Guangdong, 486). Among 5844 eligible children, 4612 (78.9%) had parental consent and completed examinations; 2957 were refracted per protocol, and 2480 (83.9%) of these had questionnaire data. Those with completed examinations were more likely to be girls (P < 0.001), and questionnaire respondents were more myopic (P = 0.02), but otherwise did not differ significantly from nonrespondents. In multivariate models, older age (P < 0.001), more near work (P = 0.02), and higher population density (P = 0.003), but not development index, parental education, or time outdoors were significantly associated with more myopic refractive error. Higher population density appears to be associated with myopia risk, independent of academic activity, time spent outdoors, familial educational level, or economic development, factors that have been thought to explain higher myopia prevalence among urban children. Mechanisms for this apparent association should be sought.

School-based Screening to Identify Children At Risk for Attention-Deficit/Hyperactivity Disorder: Barriers and Implications

PubMed Central

Barry, Tammy D.; Sturner, Raymond A.; Seymour, Karen; Howard, Barbara H.; McGoron, Lucy; Bergmann, Paul; Kent, Ronald; Sullivan, Casey; Tomeny, Theodore S.; Pierce, Jessica S.; Coin, Kristen L.; Goodlad, James K.; Werle, Nichole

2014-01-01

This report describes a school-based screening project to improve early identification of children at risk for attention-deficit/hyperactivity disorder (ADHD) and communicate these concerns to parents, recommending that they contact their child’s primary care provider (PCP). Of 17,440 eligible children in first through fifth grades in five school districts, 47.0% of parents provided required written consent, and teachers completed 70.4% of the online screeners (using the Vanderbilt AD/HD Diagnostic Teacher Rating Scale). Of 5,772 screeners completed, 18.1% of children (n = 1,044) were identified as at risk. Parents of at-risk children were contacted to explain risk status and recommended to visit their child’s PCP for further evaluation. It was not possible to contact 39.1% of parents of at-risk children. Of the 636 parents of at-risk children who could be contacted, 53.1% (n = 338) verbally accepted the recommendation to follow-up with their PCP, which was not related to ADHD symptom severity. Parents of children with IEPs or related services were more likely to accept the recommendation to visit the PCP. Our exploration of the potential for school-based screening for ADHD identified a number of barriers to successful execution, but the data also indicated that this is an important problem to address. PMID:27642209

Preventive interventions in families with parental depression: children's psychosocial symptoms and prosocial behaviour.

PubMed

Solantaus, Tytti; Paavonen, E Juulia; Toikka, Sini; Punamäki, Raija-Leena

2010-12-01

The aim is to document the effectiveness of a preventive family intervention (Family Talk Intervention, FTI) and a brief psychoeducational discussion with parents (Let's Talk about the Children, LT) on children's psychosocial symptoms and prosocial behaviour in families with parental mood disorder, when the interventions are practiced in psychiatric services for adults in the finnish national health service. Patients with mood disorder were invited to participate with their families. Consenting families were randomized to the two intervention groups. The initial sample comprised 119 families and their children aged 8-16. Of these, 109 completed the interventions and the baseline evaluation. Mothers and fathers filled out questionnaires including standardized rating scales for children's symptoms and prosocial behaviour at baseline and at 4, 10 and 18 months post-intervention. The final sample consisted of parental reports on 149 children with 83 complete data sets. Both interventions were effective in decreasing children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour. The FTI was more effective than the LT on emotional symptoms particularly immediately after the intervention, while the effect of the LT emerged after a longer interval. The study supports the effectiveness of both interventions in families with depressed parents. The FTI is applicable in cultural settings other than the USA. Our findings provide support for including preventive child mental health measures as part of psychiatric services for mentally ill parents.

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...